| ORG |
COMMITTEE |
SUB-COMMITTEE |
WORKING GROUP |
SUB-WORKING GROUP |
MEMBER |
AAMI
|
AD, Aids for Ostomy and Incontinence (U.S. TAG for ISO TC
173, SC 3) |
|
|
|
|
| AAMI |
AP, Apnea Monitoring Committee |
|
|
|
| PRIMARY: JEFFREY L
SILBERBERG, (CDRH, OSEL) | |
| AAMI |
AT, Autologous Transfusion Committee |
|
|
|
| PRIMARY: CATHERINE P
WENTZ, (CDRH, ODE) | |
| AAMI |
BE, Biological Evaluation Committee |
|
WG 01, Systematic approach to biological evaluation and
terminology |
|
| PRIMARY: JENNIFER L
GOODE, (CDRH, ODE) |
| ALTERNATE: MELVIN E
STRATMEYER, (CDRH, OSEL) | |
| AAMI |
BE, Biological Evaluation Committee |
|
WG 02, Degradation aspects related to biological testing
|
|
| ALTERNATE: AUBREY D GANTT
JR, (CDRH, ODE) |
| PRIMARY: SCOTT G
MCNAMEE, (CDRH, OC) | |
| AAMI |
BE, Biological Evaluation Committee |
|
WG 03, Animal protection aspects |
|
| PRIMARY: MELVIN E
STRATMEYER, (CDRH, OSEL) | |
AAMI
|
BE, Biological Evaluation Committee |
|
WG 04, Clinical investigations of medical devices in
humans |
|
| PRIMARY: KIMBER C
RICHTER, (CDRH, OC) |
| ALTERNATE: MARIAN J
SERGE, (CDRH, OC) | |
| AAMI |
BE, Biological Evaluation Committee |
|
WG 05, Cytotoxicity |
|
| PRIMARY: VICTORIA M
HITCHINS, (CDRH, OSEL) |
| ALTERNATE: JEFFREY
TOY, (CDRH, ODE) | |
AAMI
|
BE, Biological Evaluation Committee |
|
WG 06, Mutagenicity, cancerogenicity and reproductive
toxicity |
|
| ALTERNATE: RAMESH
PANGULURI, (CDRH, ODE) |
| PRIMARY: JEFFREY TOY,
(CDRH, ODE) | |
| AAMI |
BE, Biological Evaluation Committee |
|
WG 07, Systemic toxicity |
|
| ALTERNATE: RONALD P
BROWN, (CDRH, OSEL) |
| PRIMARY: MELVIN E
STRATMEYER, (CDRH, OSEL) | |
AAMI
|
BE, Biological Evaluation Committee |
|
WG 08, Irritation and sensitization |
|
| PRIMARY: VASANT G
MALSHET, (CDRH, ODE) |
| ALTERNATE: MRIDULIKA
VIRMANI, (CDRH, ODE) | |
| AAMI |
BE, Biological Evaluation Committee |
|
WG 09, Effects on blood |
|
| PRIMARY: JENNIFER L
GOODE, (CDRH, ODE) |
| ALTERNATE: WILLIAM G
LETZING, (CDRH, ODE) | |
| AAMI |
BE, Biological Evaluation Committee |
|
WG 10, Implantation |
|
| PRIMARY: VASANT G
MALSHET, (CDRH, ODE) |
| ALTERNATE: JEFFREY
TOY, (CDRH, ODE) | |
| AAMI |
BE, Biological Evaluation Committee |
|
WG 11, Allowable limits for leachable substances |
|
| PRIMARY: RONALD P
BROWN, (CDRH, OSEL) |
| ALTERNATE: MELVIN E
STRATMEYER, (CDRH, OSEL) | |
AAMI
|
BE, Biological Evaluation Committee |
|
WG 12, Sample preparation and reference materials |
|
| ALTERNATE: KAREEM S
BURNEY, (CDRH, ODE) |
| PRIMARY: DONALD E
MARLOWE, (OC, OSHC) | |
| AAMI |
BE, Biological Evaluation Committee |
|
WG 13, Toxicokinetics study |
|
| ALTERNATE: RONALD P
BROWN, (CDRH, OSEL) |
| PRIMARY: HOAN MY D LUU,
(CDRH, OSEL) | |
| AAMI |
BE, Biological Evaluation Committee |
|
WG 14, Material characterization |
|
| ALTERNATE: IRADA S
ISAYEVA, (CDRH, OSEL) |
| PRIMARY: STEVEN
POLLACK, (CDRH, OSEL) | |
| AAMI |
BE, Biological Evaluation Committee |
|
WG 15, Strategic approach to biological assessment |
|
| ALTERNATE: RONALD P
BROWN, (CDRH, OSEL) |
| PRIMARY: MELVIN E
STRATMEYER, (CDRH, OSEL) | |
AAMI
|
BE, Biological Evaluation Committee |
|
WG 16, Pyrogenicity |
|
| PRIMARY: VICTORIA M
HITCHINS, (CDRH, OSEL) | |
AAMI
|
BE, Biological Evaluation Committee (U.S. TAG for ISO TC
194) |
|
|
|
| ALTERNATE: DONALD E
MARLOWE, (OC, OSHC) |
| PRIMARY: MELVIN E
STRATMEYER, (CDRH, OSEL) | |
| AAMI |
BG, Blood/Gas Exchange Device Committee |
|
|
|
| PRIMARY: ARTHUR A
CIARKOWSKI, (CDRH, ODE) |
| ALTERNATE: RONALD A
ROBINSON, (CDRH, OSEL) | |
| AAMI |
BG, Blood/Gas Exchange Device Committee |
SC 02 Cardiovascular implants |
WG 06, Vascular device/drug combination products |
|
| PRIMARY: JENNIFER L
GOODE, (CDRH, ODE) |
| ALTERNATE: HINA M
PINTO, (CDRH, ODE) | |
| AAMI |
Board Healthcare Administration Vice Chair |
|
|
|
| PRIMARY: KIMBER C
RICHTER, (CDRH, OC) | |
| AAMI |
Board of Directors |
|
|
|
| PRIMARY: KIMBER C
RICHTER, (CDRH, OC) | |
| AAMI |
BP, Blood Pressure Monitoring Committee |
|
|
|
| PRIMARY: CHARLES S HO,
(CDRH, ODE) | |
| AAMI |
CI, Cochlear Implants Committee |
|
|
|
| TECH EXPERT: BRIAN B
BEARD, (CDRH, OSEL) |
| PRIMARY: JAMES K KANE,
(CDRH, ODE) |
| TECH EXPERT: VICTOR
KRAUTHAMMER, (CDRH, OSEL) |
| ALTERNATE: SRINIVAS
NANDKUMAR, (CDRH, ODE) | |
| AAMI |
Committee on Standards Strategy |
|
|
|
| PRIMARY: CAROL L
HERMAN, (CDRH, OSEL) |
| PRIMARY: DONALD E
MARLOWE, (OC, OSHC) | |
| AAMI |
CV, Cardiac Valve Prostheses Committee |
|
|
|
| PRIMARY: SANDY F
STEWART, (CDRH, OSEL) | |
| AAMI |
DF, Defibrillator Committee |
|
|
|
| PRIMARY: CAROLE C
CAREY, (CDRH, ODE) | |
AAMI
|
DI, Medical Devices for Injections Committee (U.S. TAG for
ISO TC 84) |
|
WG 01, Needle-free injections working group |
|
| PRIMARY: LANA L SHIU,
(CDRH, ODE) |
| ALTERNATE: PANDU R
SOPREY, (CDRH, ODE) | |
| AAMI |
DI, Medical Devices for Injections Committee (U.S. TAG for
ISO TC 84) |
|
WG 05, Joint TC 84 - TC 76 - TC 121/SC 03 WG: Pulmonary
devices |
|
| ALTERNATE: MICHAEL J
HUSBAND, (CDRH, ODE) |
| PRIMARY: WILLIAM C
MALONEY, (CDRH, OC) | |
| AAMI |
DP, Medical Device Particulates Committee |
|
|
|
| PRIMARY: DINESH V
PATWARDHAN, (CDRH, OSEL) |
| ALTERNATE: HINA M
PINTO, (CDRH, ODE) | |
| AAMI |
EC |
|
WG 01, Ambulatory electrocardiograph |
|
| ALTERNATE: BENJAMIN C
ELOFF, (CDRH, OSEL) |
| PRIMARY: CHARLES S HO,
(CDRH, ODE) | |
| AAMI |
EC |
|
WG 02, Arrhythmia monitoring |
|
| PRIMARY: CAROLE C
CAREY, (CDRH, ODE) | |
| AAMI |
EC |
|
WG 03, Cables and leads |
|
| PRIMARY: CAROLE C
CAREY, (CDRH, ODE) | |
AAMI
|
EC |
|
WG 04, Cardiac monitor and diagnostic ECG |
|
| PRIMARY: CHARLES S HO,
(CDRH, ODE) | |
| AAMI |
EC |
|
WG 06, ECG Electrode |
|
| PRIMARY: CAROLE C
CAREY, (CDRH, ODE) | |
| AAMI |
EC |
|
WG 08, Standard communications protocol |
|
| PRIMARY: CHARLES S HO,
(CDRH, ODE) | |
| AAMI |
EC, ECG Committee |
|
|
|
| PRIMARY: CAROLE C
CAREY, (CDRH, ODE) | |
AAMI
|
EM, Electromagnetic Compatibility Committee |
|
|
|
| PRIMARY: JEFFREY L
SILBERBERG, (CDRH, OSEL) |
| ALTERNATE: DONALD M WITTERS
JR, (CDRH, OSEL) | |
AAMI
|
EQ, Medical Equipment Management Committee |
|
|
|
|
AAMI
|
EV, (U.S. sub-TAG for IEC 62D Electromedical equipment)
|
|
WG 04, Electro-optical equipment sub-TAG |
|
| PRIMARY: NEIL R P
OGDEN, (CDRH, ODE) | |
AAMI
|
EV, (U.S. sub-TAG for IEC 62D Electromedical equipment)
|
|
WG 05, Hospital beds sub-TAG |
|
| PRIMARY: JOAN FERLO
TODD, (CDRH, OSB) |
| ALTERNATE: MATTHEW J
POWERS, (CDRH, OC) |
| ALTERNATE: MATTHEW R
SCHWERIN, (CDRH, OSEL) | |
| AAMI |
EV, (U.S. sub-TAG for IEC 62D Electromedical equipment)
|
|
WG 09, Lung ventilators |
|
| PRIMARY: MELANIE CHOE,
(CDRH, ODE) |
| ALTERNATE: JENNIFER R
MEDICUS, (CDRH, OC) | |
AAMI
|
EV, (U.S. sub-TAG for IEC 62D Electromedical equipment)
|
|
WG 12, Luminaires sub-TAG |
|
|
AAMI
|
EV, (U.S. sub-TAG for IEC 62D Electromedical equipment)
|
|
WG 13, Lens removal and vitrectomy devices for ophthalmic
surgery sub-TAG |
|
| PRIMARY: DEXIU SHI,
(CDRH, ODE) | |
AAMI
|
HE, Human Factors Engineering Committee |
|
|
|
| PRIMARY: PETER B
CARSTENSEN, (CDRH, OCER) |
| ALTERNATE: RONALD D
KAYE, (CDRH, OCER) | |
AAMI
|
HF, High Frequency Therapeutic Device Committee (U.S.
sub-TAG for IEC 62D, MT 17) |
|
|
|
| ALTERNATE: LONG H CHEN,
(CDRH, ODE) |
| PRIMARY: ROXOLANA I
HORBOWYJ, (CDRH, ODE) | |
AAMI
|
ID, Infusion Device Committee (U.S. sub-TAG for IEC 62D,
MT 23 & ISO TC 150, SC 6, WG 4) |
|
|
|
| PRIMARY: ALAN M
STEVENS, (CDRH, OC) | |
| AAMI |
ID, Infusion Device Committee (U.S. sub-TAG for IEC 62D,
MT 23 & ISO TC 150, SC 6, WG 4) |
|
WG 01, Enteral administration sets connector |
|
| PRIMARY: EILEEN K WOO,
(CDRH, OSB) | |
AAMI
|
II, Infant Incubator Committee (U.S. sub-TAG for IEC 62D,
MT 21) |
|
|
|
| ALTERNATE: WILLIAM M
BURDICK, (CDRH, ODE) |
| PRIMARY: NANCY A
PRESSLY, (CDRH, OSB) | |
| AAMI |
MC, Mechanical Circulatory Support Device Evaluation -
Preclinical testing |
|
|
|
| PRIMARY: ERIC A CHEN,
(CDRH, ODE) |
| PRIMARY: SONNA M
PATEL-RAMAN, (CDRH, ODE) | |
| AAMI |
MC, Mechanical Circulatory Support Systems Committee |
|
|
|
| PRIMARY: MICHAEL R
BERMAN, (CDRH, OSEL) |
| ALTERNATE: JEAN E
RINALDI, (CDRH, OSEL) | |
AAMI
|
Medical Device Software Committee |
|
|
|
| TECH EXPERT: BRIAN J
FITZGERALD, (CDRH, OSEL) |
| PRIMARY: JOHN F MURRAY
JR, (CDRH, OC) |
| ALTERNATE: DONNA BEA
TILLMAN, (CDRH, ODE) | |
| AAMI |
Medical Device Software Committee |
Executive Board |
|
|
| PRIMARY: JOHN F MURRAY
JR, (CDRH, OC) |
| ALTERNATE: DONNA BEA
TILLMAN, (CDRH, ODE) | |
| AAMI |
NS, Neurosurgery Committee |
|
|
|
| PRIMARY: ROBERT J DE
LUCA, (CDRH, ODE) | |
| AAMI |
NS, Neurosurgery Committee |
|
WG 02, Implantable neurostimulator |
|
| PRIMARY: STEPHEN M
HINCKLEY, (CDRH, ODE) |
| ALTERNATE: VICTOR
KRAUTHAMMER, (CDRH, OSEL) | |
| AAMI |
NS, Neurosurgery Committee |
|
WG 03, Transcutaneous electrical stimulator |
|
| PRIMARY: ROBERT J DE
LUCA, (CDRH, ODE) | |
AAMI
|
PB, Protective Barriers Committee |
|
|
|
| PRIMARY: TERRELL A
CUNNINGHAM, (CDRH, ODE) |
| ALTERNATE: SHEILA A
MURPHEY, (CDRH, ODE) | |
AAMI
|
PC, Cardiac Rhythm Management Device Committee |
|
|
|
| ALTERNATE: SETH
SEIDMAN, (CDRH, OSEL) |
| PRIMARY: MITCHELL J
SHEIN, (CDRH, ODE) | |
| AAMI |
QM, Quality Management and Corresponding General Aspects
for Medical Devices |
|
WG 01, Application of quality systems to medical devices
|
|
| PRIMARY: KIMBERLY A
TRAUTMAN, (CDRH, OC) |
| ALTERNATE: JAN WELCH,
(CDRH, OC) | |
| AAMI |
QM, Quality Management and Corresponding General Aspects
for Medical Devices |
|
WG 02, General aspects stemming from the application of
quality principles to medical devices |
|
| PRIMARY: ERIN I KEITH,
(CDRH, OC) | |
AAMI
|
QM, Quality Management and Corresponding General Aspects
for Medical Devices |
|
WG 03, Symbols and nomenclature for medical devices |
|
| PRIMARY: CAROL L
HERMAN, (CDRH, OSEL) |
| ALTERNATE: VICTORIA
WAGMAN, (CDRH, OSEL) | |
AAMI
|
QM, Quality Management and Corresponding General Aspects
for Medical Devices |
|
WG 04, Application of risk management to medical devices
|
|
| ALTERNATE: ARTHUR A
CIARKOWSKI, (CDRH, ODE) |
| PRIMARY: WILLIAM H
MIDGETTE, (CDRH, OSEL) | |
AAMI
|
QM, Quality Management and Corresponding General Aspects
for Medical Devices (US TAG for ISO/TC 210) |
|
|
|
| PRIMARY: CAROL L
HERMAN, (CDRH, OSEL) |
| ALTERNATE: KIMBERLY A
TRAUTMAN, (CDRH, OC) | |
AAMI
|
RD, Renal Disease and Detoxification Committee (U.S.
sub-TAG for IEC 62D |
|
|
|
| PRIMARY: GEMA
GONZALEZ, (CDRH, ODE) | |
AAMI
|
SP, Sphygmomanometer Committee |
|
|
|
| PRIMARY: CHARLES S HO,
(CDRH, ODE) | |
| AAMI |
Standards Board |
|
|
|
| PRIMARY: CAROL L
HERMAN, (CDRH, OSEL) | |
AAMI
|
Sterilization Standards Committee |
|
WG 01, Industrial EO sterilization |
|
| ALTERNATE: JOHN M
KUCHINSKI, (CDRH, ODE) |
| PRIMARY: STEVEN E
TURTIL, (CDRH, ODE) | |
AAMI
|
Sterilization Standards Committee |
|
WG 02, Radiation sterilization |
|
| ALTERNATE: HARRY F
BUSHAR, (CDRH, OSB) |
| ALTERNATE: MARY ANNE
MALARKEY, (CBER, OCBQ) |
| PRIMARY: PATRICK B
WEIXEL, (CDRH, OC) | |
AAMI
|
Sterilization Standards Committee |
|
WG 03, Industrial moist heat sterilization |
|
| ALTERNATE: GEETHA C
JAYAN, (ODE, DAGID) |
| PRIMARY: ELIZABETH A
RIEGEL, (CDRH, OC) | |
AAMI
|
Sterilization Standards Committee |
|
WG 04, Biological indicators |
|
| ALTERNATE: CHRISTOPHE A
DEMITRUS, (ORA, NE-FO) |
| PRIMARY: CANDACE
MCMANUS, (CDRH, OC) | |
| AAMI |
Sterilization Standards Committee |
|
WG 05, Sterilization terminology |
|
| PRIMARY: VICTORIA M
HITCHINS, (CDRH, OSEL) |
| ALTERNATE: SHARON KAY
LAPPALAINEN, (CDRH, ODE) | |
AAMI
|
Sterilization Standards Committee |
|
WG 06, Chemical indicators |
|
| ALTERNATE: MICHELLE
RIOS, (CDRH, ODE) |
| PRIMARY: JENNIFER L
SCHMIDT, (CDRH, ODE) | |
AAMI
|
Sterilization Standards Committee |
|
WG 07, Packaging |
|
| PRIMARY: VICTORIA M
HITCHINS, (CDRH, OSEL) |
| ALTERNATE: STEVEN E
TURTIL, (CDRH, ODE) | |
AAMI
|
Sterilization Standards Committee |
|
WG 08, Microbiological methods |
|
| PRIMARY: VICTORIA M
HITCHINS, (CDRH, OSEL) |
| ALTERNATE: SHARON KAY
LAPPALAINEN, (CDRH, ODE) | |
AAMI
|
Sterilization Standards Committee |
|
WG 09, Aseptic processing |
|
| PRIMARY: THOMAS J
ARISTA, (ORA, ORO) |
| ALTERNATE: ELAINE S
MAYHALL, (CDRH, ODE) | |
AAMI
|
Sterilization Standards Committee |
|
WG 10, Liquid chemical sterilization |
|
| ALTERNATE: KEVIN D
KALLANDER, (ORA, SW-FO) |
| PRIMARY: CANDACE
MCMANUS, (CDRH, OC) | |
AAMI
|
Sterilization Standards Committee |
|
WG 11, General criteria for sterilization processes |
|
| PRIMARY: CHIU S LIN,
(CDRH, ODE) |
| ALTERNATE: ALLISON A
RODRIGUEZ, (ORA, NE-FO) | |
| AAMI |
Sterilization Standards Committee |
|
WG 12, Instructions for reusable device reprocessing |
|
| PRIMARY: CHIU S LIN,
(CDRH, ODE) |
| ALTERNATE: STEVEN E
TURTIL, (CDRH, ODE) | |
AAMI
|
Sterilization Standards Committee |
|
WG 13, Washer-disinfectors |
|
| ALTERNATE: VICTORIA M
HITCHINS, (CDRH, OSEL) |
| PRIMARY: CHIU S LIN,
(CDRH, ODE) | |
AAMI
|
Sterilization Standards Committee |
|
WG 40, Steam sterilization hospital practices |
|
| PRIMARY: CANDACE
MCMANUS, (CDRH, OC) |
| ALTERNATE: ELIZABETH A
RIEGEL, (CDRH, OC) | |
| AAMI |
Sterilization Standards Committee |
|
WG 42, Dry heat sterilization |
|
| PRIMARY: ELAINE S
MAYHALL, (CDRH, ODE) |
| ALTERNATE: JENNIFER L
SCHMIDT, (CDRH, ODE) | |
AAMI
|
Sterilization Standards Committee |
|
WG 43, Hospital steam sterilizer |
|
| ALTERNATE: SHEILA A
MURPHEY, (CDRH, ODE) |
| PRIMARY: ELIZABETH A
RIEGEL, (CDRH, OC) | |
AAMI
|
Sterilization Standards Committee |
|
WG 60, EO Sterilization hospital practices |
|
| ALTERNATE: CHRISTOPHE A
DEMITRUS, (ORA, NE-FO) |
| PRIMARY: STEVEN E
TURTIL, (CDRH, ODE) | |
| AAMI |
Sterilization Standards Committee |
|
WG 61, Chemical sterilants hospital practices |
|
| ALTERNATE: ELIZABETH D
GONZALES, (ORA, SW-FO) |
| PRIMARY: CANDACE
MCMANUS, (CDRH, OC) | |
| AAMI |
Sterilization Standards Committee |
|
WG 62, Hospital EO sterilizer |
|
| ALTERNATE: JENNIFER L
SCHMIDT, (CDRH, ODE) |
| PRIMARY: STEVEN E
TURTIL, (CDRH, ODE) | |
| AAMI |
Sterilization Standards Committee |
|
WG 63, Sterilization residuals |
|
| PRIMARY: ANNE D LUCAS,
(CDRH, OSEL) |
| ALTERNATE: RAMESH
PANGULURI, (CDRH, ODE) | |
| AAMI |
Sterilization Standards Committee |
|
WG 82, Decontamination |
|
| PRIMARY: VICTORIA M
HITCHINS, (CDRH, OSEL) |
| ALTERNATE: SHARON KAY
LAPPALAINEN, (CDRH, ODE) | |
AAMI
|
Sterilization Standards Committee |
|
WG 83, Reusable surgical textiles processing |
|
| PRIMARY: SHARON KAY
LAPPALAINEN, (CDRH, ODE) |
| ALTERNATE: SHEILA A
MURPHEY, (CDRH, ODE) | |
| AAMI |
Sterilization Standards Committee |
|
WG 90, Microbiological quality (SALs) of processed medical
devices |
|
| PRIMARY: VICTORIA M
HITCHINS, (CDRH, OSEL) |
| ALTERNATE: SHARON KAY
LAPPALAINEN, (CDRH, ODE) | |
| AAMI |
Sterilization Standards Committee |
|
WG 91, Resistometer |
|
| PRIMARY: CHRISTOPHE A
DEMITRUS, (ORA, NE-FO) |
| ALTERNATE: ELAINE S
MAYHALL, (CDRH, ODE) | |
AAMI
|
Sterilization Standards Committee |
|
WG 92, Process challenge devices |
|
| ALTERNATE: GEETHA C
JAYAN, (ODE, DAGID) |
| PRIMARY: CHIU S LIN,
(CDRH, ODE) | |
| AAMI |
Sterilization Standards Committee |
|
WG 93, Cleaning of reusable medical devices |
|
| PRIMARY: VICTORIA M
HITCHINS, (CDRH, OSEL) |
| ALTERNATE: STEVEN E
TURTIL, (CDRH, ODE) | |
AAMI
|
Sterilization Standards Committee |
|
WG 94, Rigid sterilization container systems |
|
| PRIMARY: GEETHA C
JAYAN, (ODE, DAGID) |
| ALTERNATE: JENNIFER L
SCHMIDT, (CDRH, ODE) | |
AAMI
|
Sterilization Standards Committee |
|
WG 95, Water quality for reprocessing medical devices |
|
| ALTERNATE: HENRY S
CHAN, (CDRH, OCER) |
| PRIMARY: CANDACE
MCMANUS, (CDRH, OC) | |
AAMI
|
Sterilization Standards Committee |
|
WG 96, Compatibility of materials subject to sterilization
|
|
| PRIMARY: ANNE D LUCAS,
(CDRH, OSEL) |
| ALTERNATE: MICHAEL D
OHARA, (CDRH, OSEL) | |
| AAMI |
Sterilization Standards Committee |
Executive Board |
U.S. TAG for ISO TC198 |
|
| PRIMARY: VICTORIA M
HITCHINS, (CDRH, OSEL) |
| ALTERNATE: CHIU S LIN,
(CDRH, ODE) | |
| AAMI |
VP, Vascular Prostheses Committee |
|
|
|
| PRIMARY: DOROTHY B
ABEL, (CDRH, ODE) |
| ALTERNATE: JENNIFER L
GOODE, (CDRH, ODE) | |
| AAMI |
WV, Waveform Testing Committee |
|
|
|
| PRIMARY: SANDY
WEININGER, (CDRH, OSEL) | |
| AAPM |
Professional Council |
Government and Regulatory Affairs |
|
|
| PRIMARY: ROBERT A
PHILLIPS, (CDRH, ODE) | |
AAPM
|
Science Council |
Calibration Laboratory Accreditation Subcommittee |
|
|
| PRIMARY: MARY D WALKER,
(CDRH, OSEL) | |
| AAPM |
Science Council |
Calibration Laboratory Accreditation Subcommittee |
TG 51 Calibration of non-compliant beams |
|
| PRIMARY: GAMAL
AKABANI, (CDRH, ODE) | |
| AAPM |
Science Council |
Diagnostic X-Ray Imaging |
|
|
| PRIMARY: ROBERT A
PHILLIPS, (CDRH, ODE) | |
| AAPM |
Science Council |
Magnetic Resonance |
|
|
| PRIMARY: ROBERT A
PHILLIPS, (CDRH, ODE) | |
| AAPM |
Science Council |
Radiation Protection |
|
|
| PRIMARY: ROBERT A
PHILLIPS, (CDRH, ODE) | |
| AAPM |
Science Council |
Therapy Imaging |
|
|
| PRIMARY: GAMAL
AKABANI, (CDRH, ODE) | |
| AIUM |
AIUM/NEMA Joint Committee |
Output Standards Subcommittee (OSS) |
|
|
| PRIMARY: GERALD R
HARRIS, (CDRH, OSEL) | |
| AIUM |
Bioeffects Committee |
|
|
|
| PRIMARY: MELVIN E
STRATMEYER, (CDRH, OSEL) | |
| AIUM |
Technical Standards Committee |
|
|
|
| PRIMARY: KEITH A WEAR,
(CDRH, OSEL) | |
| ANSI |
Accreditation Committee |
|
|
|
| PRIMARY: DONALD E
MARLOWE, (OC, OSHC) |
| ALTERNATE: JOHN F MURRAY
JR, (CDRH, OC) | |
ANSI
|
Accredited Standards Committee C63 - Electromagnetic
Compatibility (EMC) |
|
|
|
| ALTERNATE: JEFFREY L
SILBERBERG, (CDRH, OSEL) | |
| ANSI |
Accredited Standards Committee C63 - Electromagnetic
Compatibility (EMC) |
SC 01 Techniques and Development |
|
|
| ALTERNATE: JEFFREY L
SILBERBERG, (CDRH, OSEL) | |
| ANSI |
Accredited Standards Committee C63 - Electromagnetic
Compatibility (EMC) |
SC 05 Immunity Testing and Measurements |
|
|
| ALTERNATE: JEFFREY L
SILBERBERG, (CDRH, OSEL) | |
| ANSI |
Accredited Standards Committee C63 - Electromagnetic
Compatibility (EMC) |
SC 08 Medical Device EMC Test Methods |
|
|
| ALTERNATE: JEFFREY L
SILBERBERG, (CDRH, OSEL) |
| ALTERNATE: DONALD M WITTERS
JR, (CDRH, OSEL) | |
| ANSI |
Accredited Standards Committee C63 - Electromagnetic
Compatibility (EMC) |
SC 08 Medical Device EMC Test Methods |
WG 01 Medical Device Ad Hoc EMC Test |
|
| PRIMARY: DONALD M WITTERS
JR, (CDRH, OSEL) | |
| ANSI |
Accredited Standards Committee C63 - Electromagnetic
Compatibility (EMC) |
SC 08 Medical Device EMC Test Methods |
WG 03 Hearing Aid Compatibility C63.19 |
|
| TECH EXPERT: BRIAN B
BEARD, (CDRH, OSEL) |
| PRIMARY: SRINIVAS
NANDKUMAR, (CDRH, ODE) |
| ALTERNATE: SHU-CHEN
PENG, (CDRH, ODE) | |
| ANSI |
Accredited Standards Committee on Bioacoustics S3 |
|
|
|
| PRIMARY: JAMES K KANE,
(CDRH, ODE) | |
| ANSI |
Accredited Standards Committee on Bioacoustics S3 |
|
WG 37 Coupler Calibration of Earphones |
|
| ALTERNATE: JAMES K
KANE, (CDRH, ODE) |
| PRIMARY: SRINIVAS
NANDKUMAR, (CDRH, ODE) | |
| ANSI |
Accredited Standards Committee on Bioacoustics S3 |
|
WG 48 Hearing Aids |
|
| PRIMARY: JAMES K KANE,
(CDRH, ODE) | |
| ANSI |
Accredited Standards committee on Bioacoustics S3 |
|
WG 80 Probe Tube Measurements of Hearing Aid Performance
|
|
| PRIMARY: JAMES K KANE,
(CDRH, ODE) |
| ALTERNATE: SHU-CHEN
PENG, (CDRH, ODE) | |
| ANSI |
Accredited Standards committee on Bioacoustics S3 |
|
WG 81 Hearing Assistance Technologies |
|
| PRIMARY: JAMES K KANE,
(CDRH, ODE) |
| ALTERNATE: SHU-CHEN
PENG, (CDRH, ODE) | |
| ANSI |
Acoustical Standards Management Board (ASA) |
|
|
|
| PRIMARY: MELVIN E
STRATMEYER, (CDRH, OSEL) | |
| ANSI |
ADA Standards Committee on Dental Products (ADA SCDP)
(U.S. TAG for ISO/TC 106 |
|
JWG 01 Biological evaluation |
|
| ALTERNATE: MICHAEL J
RYAN, (CDRH, ODE) | |
| ANSI |
ADA Standards Committee on Dental Products (ADA SCDP)
(U.S. TAG for ISO/TC 106) |
|
|
|
| ALTERNATE: KEVIN P
MULRY, (CDRH, ODE) |
| PRIMARY: MICHAEL J
RYAN, (CDRH, ODE) | |
| ANSI |
B 11.21 Laser Safety for Machine Tools |
|
|
|
| PRIMARY: DANIEL J
HEWETT, (CDRH, OCER) | |
| ANSI |
Board Committee on Conformity Assessment (BCCA) |
|
|
|
|
| ANSI |
Board of Directors |
|
|
|
|
| ANSI |
Executive Standards Council |
|
|
|
|
| ANSI |
Government Member Council |
|
|
|
| PRIMARY: CAROL L
HERMAN, (CDRH, OSEL) | |
| ANSI |
International Conformity Assessment Committee (ICAC) |
|
|
|
|
| ANSI |
ISO Council (AIC) |
|
|
|
| PRIMARY: CAROL L
HERMAN, (CDRH, OSEL) | |
| ANSI |
IT2 Image Evaluation |
IT2-31 X-Ray Image Evaluation |
|
|
| PRIMARY: WALID G
MOURAD, (CDRH, OCER) | |
| ANSI |
Medical Device Standards Board (MDSB) |
|
|
|
|
ANSI
|
N 43 Radiation protection from equipment for nonmedical
radiation applications |
|
|
|
| PRIMARY: DANIEL F H
KASSIDAY, (CDRH, OHIP) |
| ALTERNATE: JAMES N
WALKER, (CDRH, CONT) | |
| ANSI |
N 43 Radiation protection from equipment for nonmedical
radiation applications |
N 43.16 Radiation Safety Standard for X-Ray and Gamma
Radiation Security Non-Intrusive Inspection Systems |
|
|
| PRIMARY: DANIEL F H
KASSIDAY, (CDRH, OHIP) |
| ALTERNATE: JAMES N
WALKER, (CDRH, CONT) | |
| ANSI |
N 43 Radiation protection from equipment for nonmedical
radiation applications |
N 43.17 Radiation Safety for Personnel Security Screening
Systems Using IR |
|
|
| PRIMARY: DANIEL F H
KASSIDAY, (CDRH, OHIP) |
| ALTERNATE: JAMES N
WALKER, (CDRH, CONT) | |
| ANSI |
N 44 Equipment and Materials for Medical Radiation
Applications |
|
|
|
| PRIMARY: SANKAR P BASU,
(CDRH, ODE) | |
| ANSI |
U.S. National Committee to IEC |
|
|
|
| PRIMARY: BRIAN J
FITZGERALD, (CDRH, OSEL) | |
| ANSI |
Z 080 Ophthalmic Standards |
|
|
|
| PRIMARY: DON CALOGERO,
(CDRH, ODE) |
| ALTERNATE: ROBERT H
JAMES, (CDRH, OSEL) | |
| ANSI |
Z 080 Ophthalmic Standards |
Subcommittee 1 Prescription Spectacle Lenses |
WG 1 Spectacle Lenses Z80.1 (active) |
|
|
ANSI
|
Z 080 Ophthalmic Standards |
Subcommittee 2 Sunglasses & Fashion Eyewear |
WG 1 Sunglasses Z80.3 (active) |
|
| TECH EXPERT: GENE N
HILMANTEL, (CDRH, ODE) |
| ALTERNATE: ROBERT H
JAMES, (CDRH, OSEL) | |
| ANSI |
Z 080 Ophthalmic Standards |
Subcommittee 3 Spectacle Frames |
WG 1 Frames Z80.5 (active) |
|
|
| ANSI |
Z 080 Ophthalmic Standards |
Subcommittee 4 Medical Ophthalmic Devices |
WG 1 Intraocular Lenses Z80.7 (active) |
|
| ALTERNATE: KESIA Y
ALEXANDER, (CDRH, ODE) |
| PRIMARY: DON CALOGERO,
(CDRH, ODE) |
| TECH EXPERT: ROBERT W
FAALAND, (CDRH, OSEL) | |
ANSI
|
Z 080 Ophthalmic Standards |
Subcommittee 4 Medical Ophthalmic Devices |
WG 2 Laser Systems Z80.11 (active) |
|
| ALTERNATE: SHERYL L
BERMAN, (CDRH, ODE) |
| ALTERNATE: BRUCE A
DRUM, (CDRH, ODE) |
| PRIMARY: MALVINA B
EYDELMAN, (CDRH, ODE) |
| ALTERNATE: ROBERT W
FAALAND, (CDRH, OSEL) | |
| ANSI |
Z 080 Ophthalmic Standards |
Subcommittee 4 Medical Ophthalmic Devices |
WG 3 Multifocal IOLS Z80.12 (active) |
|
| ALTERNATE: SHERYL L
BERMAN, (CDRH, ODE) |
| PRIMARY: DON CALOGERO,
(CDRH, ODE) |
| ALTERNATE: ROBERT W
FAALAND, (CDRH, OSEL) | |
| ANSI |
Z 080 Ophthalmic Standards |
Subcommittee 4 Medical Ophthalmic Devices |
WG 4 Phakic IOLS Z80.13 (active) |
|
| PRIMARY: DON CALOGERO,
(CDRH, ODE) |
| ALTERNATE: MALVINA B
EYDELMAN, (CDRH, ODE) |
| TECH EXPERT: ROBERT W
FAALAND, (CDRH, OSEL) |
| ALTERNATE: GENE N
HILMANTEL, (CDRH, ODE) | |
| ANSI |
Z 080 Ophthalmic Standards |
Subcommittee 4 Medical Ophthalmic Devices |
WG 6 Operating Microscopes Z80.15 (inactive) |
|
| TECH EXPERT: SHARON A
MILLER, (CDRH, OSEL) |
| PRIMARY: DEXIU SHI,
(CDRH, ODE) | |
| ANSI |
Z 080 Ophthalmic Standards |
Subcommittee 4 Medical Ophthalmic Devices |
WG 7 Endoilluminators Z80.19 (inactive) |
|
| PRIMARY: SHARON A
MILLER, (CDRH, OSEL) | |
| ANSI |
Z 080 Ophthalmic Standards |
Subcommittee 4 Medical Ophthalmic Devices |
WG 8 Glaucoma Shunts Z80.27 (inactive) |
|
| PRIMARY: KESIA Y
ALEXANDER, (CDRH, ODE) |
| TECH EXPERT: KIMBERLY E
BROWN, (CDRH, ODE) |
| TECH EXPERT: BRADLEY S
CUNNINGHAM, (CDRH, ODE) | |
| ANSI |
Z 080 Ophthalmic Standards |
Subcommittee 4 Medical Ophthalmic Devices |
WG 9 Accomodative IOLS Z80.29 (active) |
|
| TECH EXPERT: KESIA Y
ALEXANDER, (CDRH, ODE) |
| ALTERNATE: SHERYL L
BERMAN, (CDRH, ODE) |
| TECH EXPERT: DON
CALOGERO, (CDRH, ODE) |
| TECH EXPERT: BRUCE A
DRUM, (CDRH, ODE) |
| TECH EXPERT: ROBERT W
FAALAND, (CDRH, OSEL) |
| PRIMARY: GENE N
HILMANTEL, (CDRH, ODE) | |
| ANSI |
Z 080 Ophthalmic Standards |
Subcommittee 4 Medical Ophthalmic Devices |
WG10 Toric IOLS Z80.30 (active) |
|
| ALTERNATE: SHERYL L
BERMAN, (CDRH, ODE) |
| PRIMARY: DON CALOGERO,
(CDRH, ODE) |
| TECH EXPERT: ROBERT W
FAALAND, (CDRH, OSEL) |
| TECH EXPERT: GENE N
HILMANTEL, (CDRH, ODE) | |
| ANSI |
Z 080 Ophthalmic Standards |
Subcommittee 5 Low Vision Devices |
WG 1 Low Vision Devices Z80.9 (inactive) |
|
| PRIMARY: BERNARD P
LEPRI, (CDRH, ODE) | |
| ANSI |
Z 080 Ophthalmic Standards |
Subcommittee 6 Ophthalmic Instruments |
WG 1 Tonometers Z80.10 (active) |
|
| TECH EXPERT: SHERYL L
BERMAN, (CDRH, ODE) |
| PRIMARY: BRUCE A DRUM,
(CDRH, ODE) |
| TECH EXPERT: GENE N
HILMANTEL, (CDRH, ODE) |
| ALTERNATE: ROBERT H
JAMES, (CDRH, OSEL) | |
| ANSI |
Z 080 Ophthalmic Standards |
Subcommittee 6 Ophthalmic Instruments |
WG 2 Visual Acuity Charts Z80.21 (active) |
|
| TECH EXPERT: SHERYL L
BERMAN, (CDRH, ODE) |
| PRIMARY: BRUCE A DRUM,
(CDRH, ODE) |
| TECH EXPERT: GENE N
HILMANTEL, (CDRH, ODE) |
| ALTERNATE: ROBERT H
JAMES, (CDRH, OSEL) | |
| ANSI |
Z 080 Ophthalmic Standards |
Subcommittee 6 Ophthalmic Instruments |
WG 3 Corneal Topography Z80.23 (active) |
|
| TECH EXPERT: SHERYL L
BERMAN, (CDRH, ODE) |
| PRIMARY: BRUCE A DRUM,
(CDRH, ODE) |
| TECH EXPERT: GENE N
HILMANTEL, (CDRH, ODE) |
| ALTERNATE: ROBERT H
JAMES, (CDRH, OSEL) | |
| ANSI |
Z 080 Ophthalmic Standards |
Subcommittee 6 Ophthalmic Instruments |
WG 4 Focimeters Z80.17 (active) |
|
| TECH EXPERT: SHERYL L
BERMAN, (CDRH, ODE) |
| PRIMARY: BRUCE A DRUM,
(CDRH, ODE) |
| TECH EXPERT: GENE N
HILMANTEL, (CDRH, ODE) |
| ALTERNATE: ROBERT H
JAMES, (CDRH, OSEL) | |
| ANSI |
Z 080 Ophthalmic Standards |
Subcommittee 6 Ophthalmic Instruments |
WG 5 Method for Reporting Optical Aberrations of Eyes
Z80.28 (active) |
|
| TECH EXPERT: SHERYL L
BERMAN, (CDRH, ODE) |
| PRIMARY: BRUCE A DRUM,
(CDRH, ODE) |
| TECH EXPERT: GENE N
HILMANTEL, (CDRH, ODE) |
| ALTERNATE: ROBERT H
JAMES, (CDRH, OSEL) | |
| ANSI |
Z 080 Ophthalmic Standards |
Subcommittee 7 Contact Lenses |
WG 1 Contact Lenses Z80.20 (active) |
|
| TECH EXPERT: CHANDRAMAL
GHOSH, (CDRH, ODE) |
| ALTERNATE: GENE N
HILMANTEL, (CDRH, ODE) |
| TECH EXPERT: JOSEPH C
HUTTER, (CDRH, OSEL) |
| TECH EXPERT: BERNARD P
LEPRI, (CDRH, ODE) |
| TECH EXPERT: MARC
ROBBOY, (CDRH, ODE) |
| TECH EXPERT: JAMES F
SAVIOLA, (CDRH, ODE) |
| TECH EXPERT: MYRA K
SMITH, (CDRH, ODE) |
| PRIMARY: KAREN F
WARBURTON, (CDRH, ODE) | |
| ANSI |
Z 080 Ophthalmic Standards |
Subcommittee 7 Contact Lenses |
WG 2 Contact Lens Care Products Z80.18 (active) |
|
| ALTERNATE: GENE N
HILMANTEL, (CDRH, ODE) |
| TECH EXPERT: JOSEPH C
HUTTER, (CDRH, OSEL) |
| TECH EXPERT: BERNARD P
LEPRI, (CDRH, ODE) |
| TECH EXPERT: MARC
ROBBOY, (CDRH, ODE) |
| TECH EXPERT: JAMES F
SAVIOLA, (CDRH, ODE) |
| TECH EXPERT: MYRA K
SMITH, (CDRH, ODE) |
| PRIMARY: KAREN F
WARBURTON, (CDRH, ODE) | |
| ANSI |
Z 080 Ophthalmic Standards |
Subcommittee 8 Information Interchange |
WG 1 Information Interchange for Instruments Z80.26
(active) |
|
|
| ANSI |
Z 080 Ophthalmic Standards |
Subcommittee 8 Information Interchange |
WG 2 Fundamental Standards Z80.25 (active) |
|
|
ANSI
|
Z 080 Ophthalmic Standards |
Subcommittee 8 Information Interchange |
WG 3 Information Interchange for Equipment Z80.24 (active)
|
|
|
ANSI
|
Z 136 Safe Use of Lasers Committee |
|
|
|
| ALTERNATE: ROBERT W
FAALAND, (CDRH, OSEL) |
| PRIMARY: RICHARD P
FELTEN, (CDRH, ODE) | |
| ANSI |
Z 136 Safe Use of Lasers Committee |
Z 136/SSC-01 Safe Use of Lasers |
|
|
| ALTERNATE: ROBERT W
FAALAND, (CDRH, OSEL) |
| PRIMARY: RICHARD P
FELTEN, (CDRH, ODE) | |
| ANSI |
Z 136 Safe Use of Lasers Committee |
Z 136/SSC-02 Safe Use of Lasers in Telecommunications |
|
|
| PRIMARY: ROBERT W
FAALAND, (CDRH, OSEL) |
| ALTERNATE: RICHARD P
FELTEN, (CDRH, ODE) | |
ANSI
|
Z 136 Safe Use of Lasers Committee |
Z 136/SSC-03 Laser Safety in Health Care Facilities |
|
|
| ALTERNATE: ROBERT W
FAALAND, (CDRH, OSEL) |
| PRIMARY: RICHARD P
FELTEN, (CDRH, ODE) | |
| ANSI |
Z 136 Safe Use of Lasers Committee |
Z 136/SSC-04 Laser Measurements |
|
|
| PRIMARY: ROBERT W
FAALAND, (CDRH, OSEL) |
| ALTERNATE: RICHARD P
FELTEN, (CDRH, ODE) | |
| ANSI |
Z 136 Safe Use of Lasers Committee |
Z 136/SSC-05 Laser Safety in Educational Facilities |
|
|
| PRIMARY: ROBERT W
FAALAND, (CDRH, OSEL) |
| ALTERNATE: RICHARD P
FELTEN, (CDRH, ODE) | |
| ANSI |
Z 136 Safe Use of Lasers Committee |
Z 136/SSC-06 Outdoor Lasers |
|
|
| PRIMARY: RICHARD P
FELTEN, (CDRH, ODE) |
| ALTERNATE: L DALE
SMITH, (CDRH, OC) | |
| ANSI |
Z 136 Safe Use of Lasers Committee |
Z 136/SSC-07 Laser Eye Protection and Barriers |
|
|
| PRIMARY: ROBERT W
FAALAND, (CDRH, OSEL) |
| ALTERNATE: RICHARD P
FELTEN, (CDRH, ODE) | |
| ANSI |
Z 136 Safe Use of Lasers Committee |
Z 136/SSC-08 Laser Safety in Research and Testing
Facilities |
|
|
| PRIMARY: ROBERT W
FAALAND, (CDRH, OSEL) |
| ALTERNATE: RICHARD P
FELTEN, (CDRH, ODE) | |
| ANSI |
Z 136 Safe Use of Lasers Committee |
Z 136/SSC-09 Laser Safety in Manufacturing Facilities |
|
|
| PRIMARY: ROBERT W
FAALAND, (CDRH, OSEL) |
| ALTERNATE: RICHARD P
FELTEN, (CDRH, ODE) | |
| ANSI |
Z 136 Safe Use of Lasers Committee |
Z 136/SSC-10 Laser Safety in Entertainment, Displays and
Exhibitions |
|
|
| PRIMARY: RICHARD P
FELTEN, (CDRH, ODE) |
| ALTERNATE: L DALE
SMITH, (CDRH, OC) | |
ANSI
|
Z 311 Photobiological Safety of Lamps and Lighting Systems
Subcommittee |
|
|
|
| ALTERNATE: EVERETTE T
BEERS, (CDRH, ODE) |
| PRIMARY: SHARON A
MILLER, (CDRH, OSEL) | |
| ASME |
Pressure Vessel for Human Occupancy (PVHO) Committee |
Subcommittee on Medical Hyperbaric Chambers |
|
|
| PRIMARY: CHRISTY L
FOREMAN, (CDRH, OC) | |
| ASQC |
Z1 Applications of Statistical Methods in Process
Management |
|
|
|
| PRIMARY: RONG TANG,
(CDRH, OSB) | |
| ASTM |
Board Committee on Standards (COS) |
|
|
|
| PRIMARY: JOHN S GOODE,
(CDRH, ODE) | |
| ASTM |
Board of Directors |
|
|
|
| PRIMARY: DONALD E
MARLOWE, (OC, OSHC) | |
ASTM
|
D11 Rubber |
D11.40 Consumer Rubber Products |
|
|
| PRIMARY: CHIU S LIN,
(CDRH, ODE) |
| ALTERNATE: DONNA L
WALSH, (CDRH, OSEL) | |
ASTM
|
D11 Rubber |
D11.40 Consumer Rubber Products |
D11.40.01 Condoms TG |
|
| ALTERNATE: LESLEY N
KERR, (ORA, NE-FO) |
| PRIMARY: COLIN M
POLLARD, (CDRH, ODE) | |
| ASTM |
D11 Rubber |
D11.40 Consumer Rubber Products |
D11.40.01 Condoms TG |
Lubricant/Latex Compatibility WG |
|
ASTM
|
D11 Rubber |
D11.40 Consumer Rubber Products |
D11.40.02 Glove Durability TG |
|
| ALTERNATE: TERRELL A
CUNNINGHAM, (CDRH, ODE) |
| PRIMARY: DONNA L WALSH,
(CDRH, OSEL) | |
| ASTM |
D11 Rubber |
D11.40 Consumer Rubber Products |
D11.40.03 Glove Expiration Dating Guidance TG |
|
| PRIMARY: DONNA L WALSH,
(CDRH, OSEL) | |
| ASTM |
D11 Rubber |
D11.40 Consumer Rubber Products |
D11.40.04 ELISA TG |
|
| PRIMARY: ANNE D LUCAS,
(CDRH, OSEL) | |
| ASTM |
D11 Rubber |
D11.40 Consumer Rubber Products |
D11.40.06 Latex Chemical Sensitivity TG |
|
| ALTERNATE: GEETHA C
JAYAN, (ODE, DAGID) |
| PRIMARY: ANNE D LUCAS,
(CDRH, OSEL) | |
| ASTM |
D11 Rubber |
D11.40 Consumer Rubber Products |
D11.40.08 IEMA TG |
|
| ALTERNATE: ANNE D
LUCAS, (CDRH, OSEL) |
| PRIMARY: MELVIN E
STRATMEYER, (CDRH, OSEL) | |
| ASTM |
D11 Rubber |
D11.40 Consumer Rubber Products |
D11.40.09 Chemotherapy Gloves TG |
|
| PRIMARY: TERRELL A
CUNNINGHAM, (CDRH, ODE) | |
| ASTM |
D11 Rubber |
D11.40 Consumer Rubber Products |
D11.40.10 Medical Glove Selection Guide TG |
|
| PRIMARY: TERRELL A
CUNNINGHAM, (CDRH, ODE) | |
ASTM
|
D11 Rubber |
D11.40 Consumer Rubber Products |
D11.40.12 Medical Glove TG |
|
| PRIMARY: CHIU S LIN,
(CDRH, ODE) |
| ALTERNATE: DONNA L
WALSH, (CDRH, OSEL) | |
| ASTM |
D11 Rubber |
D11.40 Consumer Rubber Products |
D11.40.12 Medical Glove TG |
Maximum Powder Working Group |
| ALTERNATE: MARIA P
CHAPUT, (ORA, NE-FO) |
| PRIMARY: CHIU S LIN,
(CDRH, ODE) | |
| ASTM |
D11 Rubber |
D11.40 Consumer Rubber Products |
D11.40.14 Radiation Attenuation Medical Glove TG |
|
| PRIMARY: TERRELL A
CUNNINGHAM, (CDRH, ODE) | |
| ASTM |
D11 Rubber |
D11.40 Consumer Rubber Products |
D11.40.18 Detection of Holes in Medical Gloves |
|
| ALTERNATE: MARIA P
CHAPUT, (ORA, NE-FO) |
| PRIMARY: TERRELL A
CUNNINGHAM, (CDRH, ODE) | |
ASTM
|
E10 Nuclear Technology and Applications |
E10.01 Dosimetry for Radiation Processing |
|
|
| ALTERNATE: KIM M
MOREHOUSE, (CFSAN, ORS) |
| PRIMARY: PATRICK B
WEIXEL, (CDRH, OC) | |
ASTM
|
E20 Temperature Measurement |
E20.08 Medical Thermometry |
|
|
| PRIMARY: WILLIAM M
BURDICK, (CDRH, ODE) | |
| ASTM |
E31 Healthcare Informatics |
|
|
|
| ALTERNATE: ALBERTO
GUTIEREZ, (CDRH, OIVD) |
| PRIMARY: CLARA A SLIVA,
(CBER, OCBQ) | |
| ASTM |
E31 Healthcare Informatics |
E31.13 Clinical Laboratory Information Management |
|
|
| PRIMARY: CLARA A SLIVA,
(CBER, OCBQ) | |
| ASTM |
E48 Biotechnology |
|
|
|
| PRIMARY: AVRAHAM
RASOOLY, (CFSAN, OPDFB) | |
| ASTM |
F 29 Anesthetic and Respiratory Equipment |
F29.90 Executive |
|
|
|
| ASTM |
F02 Flexible Barrier Materials |
|
|
|
| ALTERNATE: SRILEKHA S
DAS, (CDRH, OSEL) |
| PRIMARY: PATRICK B
WEIXEL, (CDRH, OC) | |
| ASTM |
F02 Flexible Barrier Materials |
F02.60 Medical Packaging |
|
|
| ALTERNATE: STEVEN E
TURTIL, (CDRH, ODE) |
| PRIMARY: PATRICK B
WEIXEL, (CDRH, OC) | |
ASTM
|
F04 Medical and Surgical Materials and Devices |
|
|
|
| ALTERNATE: KEITH E FOY,
(CDRH, ODE) |
| PRIMARY: MARK N
MELKERSON, (CDRH, ODE) | |
ASTM
|
F04 Medical and Surgical Materials and Devices |
F04.05 Computer Assisted Orthopaedic Surgical Systems |
|
|
| ALTERNATE: LONG H CHEN,
(CDRH, ODE) |
| PRIMARY: DWIGHT YEN,
(CDRH, ODE) | |
ASTM
|
F04 Medical and Surgical Materials and Devices |
F04.11 Polymeric Materials |
|
|
| PRIMARY: HANY W DEMIAN,
(CDRH, ODE) |
| ALTERNATE: JOHN S
GOODE, (CDRH, ODE) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.11 Polymeric Materials |
F04.11.04 Poly-L-Lactic Acid (PLLA) |
|
| PRIMARY: HANY W DEMIAN,
(CDRH, ODE) |
| ALTERNATE: JOHN S
GOODE, (CDRH, ODE) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.11 Polymeric Materials |
F04.11.06 Bioabsorable Polymer-Degradation Test Methods
|
|
| PRIMARY: HANY W DEMIAN,
(CDRH, ODE) |
| ALTERNATE: JOHN S
GOODE, (CDRH, ODE) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.11 Polymeric Materials |
F04.11.07 Rev F 451 Acrylic Bone Cement |
|
| PRIMARY: HANY W DEMIAN,
(CDRH, ODE) |
| ALTERNATE: JOHN S
GOODE, (CDRH, ODE) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.11 Polymeric Materials |
F04.11.08 Revision of F648 UHMWPE |
|
| PRIMARY: HANY W DEMIAN,
(CDRH, ODE) |
| ALTERNATE: JOHN S
GOODE, (CDRH, ODE) | |
ASTM
|
F04 Medical and Surgical Materials and Devices |
F04.12 Metallurgical Materials |
|
|
| ALTERNATE: DANIEL C
CLUPPER, (CDRH, ODE) |
| ALTERNATE: DANIEL C
CLUPPER, (CDRH, ODE) |
| PRIMARY: DAVID M
SAYLOR, (CDRH, OSEL) | |
ASTM
|
F04 Medical and Surgical Materials and Devices |
F04.13 Ceramic Materials |
|
|
| PRIMARY: PETER G ALLEN,
(CDRH, ODE) |
| ALTERNATE: ERIN I
KEITH, (CDRH, OC) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.13 Ceramic Materials |
F04.13.04 Rev F 603-Polycrystalline Alumina |
|
| PRIMARY: PETER G ALLEN,
(CDRH, ODE) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.13 Ceramic Materials |
F04.13.05 CPC Crystalline Characterization |
|
| PRIMARY: PETER G ALLEN,
(CDRH, ODE) | |
ASTM
|
F04 Medical and Surgical Materials and Devices |
F04.15 Material Test Methods |
|
|
| ALTERNATE: HANY W
DEMIAN, (CDRH, ODE) |
| PRIMARY: TERRY O WOODS,
(CDRH, OSEL) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.15 Material Test Methods |
F04.15.08 Abrasion of Coatings |
|
| PRIMARY: PETER G ALLEN,
(CDRH, ODE) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.15 Material Test Methods |
F04.15.11 MR Standards |
|
| ALTERNATE: WOLFGANG
KAINZ, (CDRH, OSEL) |
| PRIMARY: TERRY O WOODS,
(CDRH, OSEL) | |
ASTM
|
F04 Medical and Surgical Materials and Devices |
F04.16 Biocompatibility Test Methods |
|
|
| PRIMARY: MELVIN E
STRATMEYER, (CDRH, OSEL) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.16 Biocompatibility Test Methods |
F04.16.01 Biological Response to Particle Debris |
|
| PRIMARY: VICTORIA M
HITCHINS, (CDRH, OSEL) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.16 Biocompatibility Test Methods |
F04.16.05 Recovery of Foreign Particles from Tissue |
|
| PRIMARY: VICTORIA M
HITCHINS, (CDRH, OSEL) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.16 Biocompatibility Test Methods |
F04.16.08 Immunological Testing |
|
| PRIMARY: JOHN J
LANGONE, (CDRH, OSEL) |
| ALTERNATE: DANIEL B
LYLE, (CDRH, OSEL) | |
ASTM
|
F04 Medical and Surgical Materials and Devices |
F04.18 Device Retrieval Analysis |
|
|
| PRIMARY: ERIN I KEITH,
(CDRH, OC) |
| ALTERNATE: DONALD E
MARLOWE, (OC, OSHC) | |
ASTM
|
F04 Medical and Surgical Materials and Devices |
F04.21 Osteosynthesis |
|
|
| ALTERNATE: SERGIO M DE DEL
CASTILLO, (CDRH, ODE) |
| PRIMARY: RONALD P JEAN,
(CDRH, ODE) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.21 Osteosynthesis |
F04.21.01 Bone Screws |
|
| PRIMARY: RONALD P JEAN,
(CDRH, ODE) |
| ALTERNATE: DONALD E
MARLOWE, (OC, OSHC) |
| ALTERNATE: JONATHAN H
PECK, (CDRH, ODE) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.21 Osteosynthesis |
F04.21.05 Bone Staples |
|
| PRIMARY: RONALD P JEAN,
(CDRH, ODE) |
| ALTERNATE: DONALD E
MARLOWE, (OC, OSHC) |
| ALTERNATE: JONATHAN H
PECK, (CDRH, ODE) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.21 Osteosynthesis |
F04.21.06 Fixation Wire and Cable |
|
| PRIMARY: RONALD P JEAN,
(CDRH, ODE) |
| ALTERNATE: DONALD E
MARLOWE, (OC, OSHC) |
| ALTERNATE: JONATHAN H
PECK, (CDRH, ODE) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.21 Osteosynthesis |
F04.21.11 Bone Plates |
|
| PRIMARY: RONALD P JEAN,
(CDRH, ODE) |
| ALTERNATE: DONALD E
MARLOWE, (OC, OSHC) |
| ALTERNATE: JONATHAN H
PECK, (CDRH, ODE) | |
ASTM
|
F04 Medical and Surgical Materials and Devices |
F04.22 Arthroplasty |
|
|
| ALTERNATE: HANY W
DEMIAN, (CDRH, ODE) |
| PRIMARY: JOHN S GOODE,
(CDRH, ODE) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.22 Arthroplasty |
F04.22.01 Modular Tibial Stem Test Method |
|
| PRIMARY: JOHN S GOODE,
(CDRH, ODE) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.22 Arthroplasty |
F04.22.09 Femoral Stem Test Method |
|
| ALTERNATE: HANY W
DEMIAN, (CDRH, ODE) |
| PRIMARY: JOHN S GOODE,
(CDRH, ODE) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.22 Arthroplasty |
F04.22.10 Hip Wear |
|
| ALTERNATE: HANY W
DEMIAN, (CDRH, ODE) |
| PRIMARY: JOHN S GOODE,
(CDRH, ODE) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.22 Arthroplasty |
F04.22.14 Total Knee Specification |
|
| PRIMARY: PETER G ALLEN,
(CDRH, ODE) |
| ALTERNATE: JOHN S
GOODE, (CDRH, ODE) | |
ASTM
|
F04 Medical and Surgical Materials and Devices |
F04.25 Spinal Devices |
|
|
| ALTERNATE: MARK N
MELKERSON, (CDRH, ODE) |
| PRIMARY: JONATHAN H
PECK, (CDRH, ODE) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.25 Spinal Devices |
F04.25.01 Spinal Terminology |
|
| PRIMARY: JONATHAN H
PECK, (CDRH, ODE) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.25 Spinal Devices |
F04.25.02 Component Testing |
|
| ALTERNATE: SERGIO M DE DEL
CASTILLO, (CDRH, ODE) |
| PRIMARY: JONATHAN H
PECK, (CDRH, ODE) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.25 Spinal Devices |
F04.25.03 Spinal Component - Component Interfaces |
|
| ALTERNATE: JODI HOPE N
ANDERSON, (CDRH, ODE) |
| PRIMARY: JONATHAN H
PECK, (CDRH, ODE) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.25 Spinal Devices |
F04.25.04 Spinal Constructs |
|
| ALTERNATE: JODI HOPE N
ANDERSON, (CDRH, ODE) |
| PRIMARY: JONATHAN H
PECK, (CDRH, ODE) | |
ASTM
|
F04 Medical and Surgical Materials and Devices |
F04.30 Cardiovascular Standards |
|
|
| PRIMARY: JEAN E
RINALDI, (CDRH, OSEL) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.30 Cardiovascular Standards |
F04.30.06 Interventional Cardiology |
|
| ALTERNATE: HEATHER
AGLER, (CDRH, ODE) |
| PRIMARY: KENNETH J
CAVANAUGH, (CDRH, ODE) | |
ASTM
|
F04 Medical and Surgical Materials and Devices |
F04.32 Plastic and Reconstructive Surgery |
|
|
| ALTERNATE: GEORGE K
NGATHA, (CDRH, ODE) |
| PRIMARY: STEPHEN P
RHODES, (CDRH, ODE) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.32 Plastic and Reconstructive Surgery |
F04.32.01 Mammary Implants |
|
| ALTERNATE: LISA M LIM,
(CDRH, ODE) |
| PRIMARY: HOAN MY D LUU,
(CDRH, OSEL) | |
ASTM
|
F04 Medical and Surgical Materials and Devices |
F04.33 Medical/Surgical Instruments |
|
|
| PRIMARY: LONG H CHEN,
(CDRH, ODE) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.34 Urological Materials and Devices |
|
|
| ALTERNATE: CHRISTINA L
BEARDSLEY, (CDRH, ODE) |
| PRIMARY: VENKAT RAO
NIMMAGADDA, (CDRH, ODE) | |
ASTM
|
F04 Medical and Surgical Materials and Devices |
F04.35 GI Applications |
|
|
| PRIMARY: MARY JOAN
CORNELIUS, (CDRH, ODE) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.37 Implantable Hearing Devices |
|
|
| ALTERNATE: BRIAN B
BEARD, (CDRH, OSEL) |
| PRIMARY: JAMES K KANE,
(CDRH, ODE) | |
ASTM
|
F04 Medical and Surgical Materials and Devices |
F04.41 Classification and Terminology for TEMPs |
|
|
| ALTERNATE: RABIA
BALLICA, (CBER, OCTGT) |
| PRIMARY: MALCOLM C
MOOS, (CBER, OCTGT) | |
ASTM
|
F04 Medical and Surgical Materials and Devices |
F04.42 Biomaterials and Biomolecules for TEMPs |
|
|
| ALTERNATE: RAKHI M
DALAL, (CDRH, OSEL) |
| PRIMARY: DAVID S
KAPLAN, (CDRH, OSEL) | |
ASTM
|
F04 Medical and Surgical Materials and Devices |
F04.43 Cells and Tissue Engineered Constructs for TEMPs
|
|
|
| PRIMARY: CHARLES N
DURFOR, (CDRH, ODE) |
| TECH EXPERT: RICHARD D
MCFARLAND, (CBER, OCTGT) | |
ASTM
|
F04 Medical and Surgical Materials and Devices |
F04.44 Assessment for TEMPs |
|
|
| ALTERNATE: ARIC D
KAISER, (CDRH, ODE) |
| PRIMARY: DAVID KRAUSE,
(CDRH, ODE) | |
ASTM
|
F04 Medical and Surgical Materials and Devices |
F04.45 Adventitious Agents Safety |
|
|
| PRIMARY: KIMBERLY A
BENTON, (CBER, OCTGT) |
| ALTERNATE: JEFFREY
TOY, (CDRH, ODE) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.46 Cell Signaling |
|
|
| PRIMARY: MALCOLM C
MOOS, (CBER, OCTGT) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.93 on US TAG ISO/TC 150 - Implants for Surgery |
|
|
| ALTERNATE: JOHN S
GOODE, (CDRH, ODE) |
| PRIMARY: MARK N
MELKERSON, (CDRH, ODE) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.93.03 Neurosurgical Implants |
|
|
| PRIMARY: JEAN E
RINALDI, (CDRH, OSEL) |
| ALTERNATE: TERRY O
WOODS, (CDRH, OSEL) | |
| ASTM |
F04 Medical and Surgical Materials and Devices |
F04.95 on US TAG ISO/TC 168 - Prosthetics and Orthotics
|
|
|
| PRIMARY: DONALD E
MARLOWE, (OC, OSHC) | |
ASTM
|
F12 Security Systems and Equipment |
F12.60 Controlled Access Security, Search and Screening
Equipment |
F12.63 Task Group on Weapons Detection |
|
| ALTERNATE: JON P
CASAMENTO, (CDRH, OSEL) |
| PRIMARY: DONALD M WITTERS
JR, (CDRH, OSEL) | |
ASTM
|
F23 Protective Clothing |
F23.40 Biological |
|
|
| PRIMARY: TERRELL A
CUNNINGHAM, (CDRH, ODE) |
| ALTERNATE: SHEILA A
MURPHEY, (CDRH, ODE) | |
ASTM
|
F23 Protective Clothing |
F23.40 Biological |
F23.40.07 Surgical Gowns Task Group |
|
| PRIMARY: HARRY R
SAUBERMAN, (CDRH, ODE) | |
| ASTM |
F29 Anesthetic and Respiratory Equipment |
F29.10 Anesthesia Workstations |
F29.10.01 Anesthesia Gas Machines |
|
| PRIMARY: KIMBERLY G
LOVE, (CDRH, ODE) | |
ASTM
|
F29 Anesthetic and Respiratory Equipment |
F29.11 Gas Monitors |
F29.11.01 Capnographs and Anesthetic Agent Analyzers |
|
| ALTERNATE: MICHAEL J
HUSBAND, (CDRH, ODE) |
| PRIMARY: NEEL J PATEL,
(CDRH, ODE) | |
| ASTM |
F29 Anesthetic and Respiratory Equipment |
F29.12 Airways, Bronchoscopes and Laryngoscopes |
|
|
| PRIMARY: CHARLES M
KERNS, (CDRH, ODE) | |
ASTM
|
F29 Anesthetic and Respiratory Equipment |
F29.14 Ventilators |
|
|
| PRIMARY: MELANIE CHOE,
(CDRH, ODE) |
| ALTERNATE: JENNIFER R
MEDICUS, (CDRH, OC) | |
| ASTM |
F29 Anesthetic and Respiratory Equipment |
F29.21 Closed Loop Controller Task Group |
|
|
|
| ASTM |
F29 Anesthetic and Respiratory Equipment |
F29.21 Closed Loop Controller Task Group |
|
|
| PRIMARY: MICHAEL J
HUSBAND, (CDRH, ODE) |
| ALTERNATE: SANDY
WEININGER, (CDRH, OSEL) | |
ASTM
|
F29 Anesthetic and Respiratory Equipment |
F29.91(US TAG to ISO TC 121) |
|
|
| ALTERNATE: MELANIE
CHOE, (CDRH, ODE) |
| PRIMARY: NEEL J PATEL,
(CDRH, ODE) | |
ASTM
|
G03 Committee on Weathering and Durability |
|
|
|
| PRIMARY: SRILEKHA S
DAS, (CDRH, OSEL) | |
ASTM
|
G04 Compatibility and Sensitivity of Materials in Oxygen
Enriched Atmospheres |
|
|
|
| ALTERNATE: MELANIE
CHOE, (CDRH, ODE) |
| PRIMARY: CHRISTY L
FOREMAN, (CDRH, OC) | |
| CIE |
International Commission on Illumination (CIE) Div. 6 -
Photobiology and Photochemistry |
|
|
|
| PRIMARY: JANUSZ Z BEER,
(CDRH, OSEL) | |
CLSI
|
Area Committee on Automation and Informatics |
|
|
|
| PRIMARY: JAMES V
CALLAGHAN, (CDRH, OIVD) |
| ALTERNATE: EUGENE T
REILLY, (CDRH, OIVD) | |
| CLSI |
Area Committee on Clinical Chemistry and Toxicology |
|
Working Group on Reference Intervals in the Clinical
Laboratory |
|
| PRIMARY: SOUSAN S
ALTAIE, (CDRH, OIVD) |
| ALTERNATE: VICKI A
MOYER, (CDRH, OIVD) | |
| CLSI |
Area Committee on Clinical Chemistry and Toxicology |
Subcommittee on Expression of Uncertainty of Measurement
in Clinical Laboratory Medicine |
|
|
| PRIMARY: GENE A
PENNELLO, (CDRH, OSB) | |
| CLSI |
Area Committee on Clinical Chemistry and Toxicology |
Subcommittee on Protocols for Establishment of Sample
Stability in Clinical Chemistry and Toxicology |
|
|
| PRIMARY: SOUSAN S
ALTAIE, (CDRH, OIVD) | |
| CLSI |
Area Committee on Evaluation Protocols |
|
|
|
| PRIMARY: RAMA L
VISHNUVAJJALA, (CDRH, OSB) | |
| CLSI |
Area Committee on Evaluation Protocols |
Evaluating Between Reagent Lot Variation |
|
|
| ALTERNATE: ARKENDRA K
DE, (CDRH, OSB) |
| PRIMARY: TENA T WEI,
(CDRH, OIVD) | |
| CLSI |
Area Committee on Evaluation Protocols |
Evaluating Between Reagent Lot Variation |
|
|
|
| CLSI |
Area Committee on Evaluation Protocols |
Subcommittee on Assessment of Laboratory Tests using ROC
Plots |
|
|
| ALTERNATE: THOMAS E
GWISE, (CDRH, OSB) |
| PRIMARY: KYUNGHEE K
SONG, (CDRH, OSB) | |
| CLSI |
Area Committee on Evaluation Protocols |
Subcommittee on Evaluation of Precision |
|
|
| PRIMARY: SAMIR
LABABIDI, (CDRH, OSB) | |
| CLSI |
Area Committee on Evaluation Protocols |
Subcommittee on Evaluation of Stability of In Vitro
Diagnostic Method Products |
|
|
|
| CLSI |
Area Committee on Evaluation Protocols |
Subcommittee on Evaluation of Stability of In Vitro
Diagnostic Method Products |
|
|
| PRIMARY: SOUSAN S
ALTAIE, (CDRH, OIVD) | |
| CLSI |
Area Committee on Evaluation Protocols |
Subcommittee on Presentation of Manufacturers Risk
Mitigation Information |
|
|
| PRIMARY: DAI J LI,
(CDRH, OIVD) | |
| CLSI |
Area Committee on Evaluation Protocols |
Subcommittee on Risk Management Techniques |
|
|
| PRIMARY: SOUSAN S
ALTAIE, (CDRH, OIVD) | |
| CLSI |
Area Committee on Evaluation Protocols |
Subcommittee on User Defined QC Protocols for in vitro
Diagnostic Devices |
|
|
| PRIMARY: DAI J LI,
(CDRH, OIVD) |
| ALTERNATE: ARLEEN F
PINKOS, (CDRH, OIVD) | |
| CLSI |
Area Committee on General Laboratory Practices |
|
|
|
| PRIMARY: TREMEL A
FAISON, (CDRH, OIVD) |
| ALTERNATE: STEVEN I
GUTMAN, (CDRH, OIVD) | |
CLSI
|
Area Committee on Hematology |
|
|
|
| PRIMARY: JOSEPHINE M
BAUTISTA, (CDRH, OIVD) |
| ALTERNATE: LARRY J
BRINDZA, (CDRH, OIVD) | |
| CLSI |
Area Committee on Hematology |
Subcommittee on Blood Count |
|
|
| PRIMARY: LOUISE E
MAGRUDER, (CDRH, OIVD) | |
CLSI
|
Area Committee on Hematology |
Subcommittee on Coagulation Testing |
|
|
| PRIMARY: LARRY J
BRINDZA, (CDRH, OIVD) |
| ALTERNATE: GINETTE Y
MICHAUD, (CDRH, OIVD) | |
| CLSI |
Area Committee on Hematology |
Subcommittee on Platelet Function Testing |
|
|
| PRIMARY: LEONTHENA R
CARRINGTON, (CDRH, OIVD) |
| ALTERNATE: QIJIN LU,
(CDRH, OSEL) | |
CLSI
|
Area Committee on Immunology and Ligand Assay |
|
|
|
| PRIMARY: MARILYN M
LIGHTFOOTE, (CDRH, OSEL) | |
| CLSI |
Area Committee on Immunology and Ligand Assay |
Subcommittee on Diagnostic Allergy Techniques |
|
|
| PRIMARY: JAMES P
REEVES, (CDRH, OIVD) | |
| CLSI |
Area Committee on Immunology and Ligand Assay |
Subcommittee on Interference by Heterophile Antibodies |
|
|
| PRIMARY: NINA M CHACE,
(CDRH, OIVD) | |
| CLSI |
Area Committee on Immunology and Ligand Assay |
Subcommittee on Quality Assurance for Immunocytochemistry
|
|
|
| PRIMARY: MAX
ROBINOWITZ, (CDRH, OIVD) |
| TECH EXPERT: JAN
WELCH, (CDRH, OC) | |
CLSI
|
Area Committee on Microbiology |
|
|
|
| ALTERNATE: SALLY A
HOJVAT, (CDRH, OIVD) |
| PRIMARY: FREDDIE M
POOLE, (CDRH, OIVD) | |
| CLSI |
Area Committee on Microbiology |
Subcommittee on Antifungal Susceptibility Tests |
|
|
| PRIMARY: FREDDIE M
POOLE, (CDRH, OIVD) | |
| CLSI |
Area Committee on Microbiology |
Subcommittee on Antimicrobial Susceptibility Testing |
|
|
| PRIMARY: FREDDIE M
POOLE, (CDRH, OIVD) | |
| CLSI |
Area Committee on Microbiology |
Subcommittee on Antimicrobial Susceptibility Testing of
Human Mycoplasma |
|
|
| ALTERNATE: SOUSAN S
ALTAIE, (CDRH, OIVD) |
| PRIMARY: TONYA A
WILBON, (CDRH, OIVD) | |
| CLSI |
Area Committee on Microbiology |
Subcommittee on Antimycobacterial Susceptibility Testing
|
|
|
| PRIMARY: MARIEANN R
BRILL, (CDRH, OIVD) | |
| CLSI |
Area Committee on Microbiology |
Subcommittee on Culture Media |
|
|
| PRIMARY: ROXANNE G
SHIVELY, (CDRH, OIVD) | |
| CLSI |
Area Committee on Microbiology |
Subcommittee on Quality Control for Commercial Microbial
Identification Systems |
|
|
|
CLSI
|
Area Committee on Molecular Methods |
|
|
|
| PRIMARY: UWE SCHERF,
(CDRH, OIVD) |
| ALTERNATE: ZIVANA
TEZAK-FRAGALE, (CDRH, OIVD) |
| ALTERNATE: ZIVANA
TEZAK-FRAGALE, (CDRH, OIVD) | |
| CLSI |
Area Committee on Molecular Methods |
Subcommitee on Nucleic Acid Amplification Assays for
Molecular Hematopathology |
|
|
| PRIMARY: KAREN E
BIJWAARD, (CDRH, OIVD) |
| ALTERNATE: LAN T
NGUYEN, (CDRH, OIVD) | |
| CLSI |
Area Committee on Molecular Methods |
Subcommittee on Microorganism Id by DNA Target Sequencing
|
|
|
| PRIMARY: TAMARA V
FELDBLYUM, (CDRH, OIVD) |
| ALTERNATE: LI LI,
(ORA, CE-FO) | |
| CLSI |
Area Committee on Molecular Methods |
Subcommittee on Verification and Validation of Multiplex
Nucleic Acid Assays |
|
|
| ALTERNATE: KAREN E
BIJWAARD, (CDRH, OIVD) |
| PRIMARY: ZIVANA
TEZAK-FRAGALE, (CDRH, OIVD) |
| PRIMARY: ZIVANA
TEZAK-FRAGALE, (CDRH, OIVD) | |
CLSI
|
Area Committee on Point-of-Care Testing |
|
|
|
| PRIMARY: ANN MARIE P
CHAPPIE, (CDRH, OIVD) | |
| CLSI |
Area Committee on Point-of-Care Testing |
Subcommittee on Continuous Interstitial Glucose Monitoring
|
|
|
| PRIMARY: PATRICIA A
BERNHARDT, (CDRH, OIVD) |
| ALTERNATE: ARLEEN F
PINKOS, (CDRH, OIVD) |
| TECH EXPERT: CHARLES L
ZIMLIKI, (CDRH, ODE) | |
| CLSI |
Area Committee on Point-of-Care Testing |
Subcommittee on Implementation of POCT1 by Healthcare
Providers |
|
|
| PRIMARY: ANN MARIE P
CHAPPIE, (CDRH, OIVD) | |
| CLSI |
Area Committee on Point-of-Care Testing |
Subcommittee on Implementation of POCT1 by Manufacturers
|
|
|
| PRIMARY: DOUGLAS O
WOOD, (CDRH, OIVD) | |
CLSI
|
Area Committee on Point-of-Care Testing |
Subcommittee on Method Comparison of Glucose Methodologies
|
|
|
| PRIMARY: ANN MARIE P
CHAPPIE, (CDRH, OIVD) |
| ALTERNATE: VICKI A
MOYER, (CDRH, OIVD) | |
| CLSI |
Area Committee on Quality Systems and Laboratory Practices
|
|
|
|
| ALTERNATE: SOUSAN S
ALTAIE, (CDRH, OIVD) |
| PRIMARY: TONYA A
WILBON, (CDRH, OIVD) | |
| CLSI |
Area Committee on Quality Systems and Laboratory Practices
|
Subcommittee on Tubes and Additives for Venous Blood
Specimen Collection |
|
|
|
| CLSI |
Area Committee on Quality Systems and Laboratory Practices
|
Subcommittee on Validation of Blood Sample Collection
Devices |
|
|
|
| CLSI |
Area Committee on Quality Systems and Laboratory Practices
|
Validation of Evacuated Blood Collection Tubes |
|
|
| PRIMARY: YUNG W CHAN,
(CDRH, OIVD) | |
| CLSI |
Board of Directors |
|
|
|
| PRIMARY: LILIAN J GILL,
(CDRH, OCD) | |
| CLSI |
Delegate |
|
|
|
| ALTERNATE: STEVEN I
GUTMAN, (CDRH, OIVD) |
| PRIMARY: CAROL L
HERMAN, (CDRH, OSEL) | |
| IEC |
JWG |
|
Joint Working Group 1 (JWG) Cardiac Pacemakers (ISO TC
150/SC6/WG2 & IEC 62D/WG6) |
|
| TECH EXPERT: CAROLE C
CAREY, (CDRH, ODE) |
| PRIMARY: MITCHELL J
SHEIN, (CDRH, ODE) | |
IEC
|
TC 029 Electroacoustics |
|
WG 13 Hearing aids |
|
| PRIMARY: JAMES K KANE,
(CDRH, ODE) | |
| IEC |
TC 056 Dependability |
|
|
|
| PRIMARY: WILLIAM H
MIDGETTE, (CDRH, OSEL) | |
IEC
|
TC 061 Safety of household and similar electrical
appliances |
|
|
MT 16 Ultra-violet radiation |
| ALTERNATE: JANUSZ Z
BEER, (CDRH, OSEL) |
| PRIMARY: SHARON A
MILLER, (CDRH, OSEL) | |
| IEC |
TC 061 Safety of household and similar electrical
appliances |
SC 61B Safety of microwave ovens |
|
|
| PRIMARY: GEORGE W KRAUS
JR, (CDRH, OCER) | |
| IEC |
TC 062 Electrical equipment in medical practice |
|
|
|
| PRIMARY: SANDY
WEININGER, (CDRH, OSEL) |
| ALTERNATE: DONALD M WITTERS
JR, (CDRH, OSEL) | |
IEC
|
TC 062 Electrical equipment in medical practice |
SC 62A Common aspects of electrical equipment used in
medical practice |
|
|
| ALTERNATE: SAJJAD H
SYED, (CDRH, ODE) |
| PRIMARY: SANDY
WEININGER, (CDRH, OSEL) | |
IEC
|
TC 062 Electrical equipment in medical practice |
SC 62A Common aspects of electrical equipment used in
medical practice |
|
MT 23 Electromagnetic compatibility |
| PRIMARY: JEFFREY L
SILBERBERG, (CDRH, OSEL) | |
| IEC |
TC 062 Electrical equipment in medical practice |
SC 62A Common aspects of electrical equipment used in
medical practice |
WG 05 Ergonomics and graphical symbols |
|
| PRIMARY: PETER B
CARSTENSEN, (CDRH, OCER) | |
| IEC |
TC 062 Electrical equipment in medical practice |
SC 62A Common aspects of electrical equipment used in
medical practice |
WG 15 Risk management |
|
| PRIMARY: WILLIAM H
MIDGETTE, (CDRH, OSEL) | |
| IEC |
TC 062 Electrical equipment in medical practice |
SC 62A Common aspects of electrical equipment used in
medical practice |
WG 16 Electrical hazards |
|
| PRIMARY: RAY L WALCHLE,
(CDRH, OSEL) | |
| IEC |
TC 062 Electrical equipment in medical practice |
SC 62A Common aspects of electrical equipment used in
medical practice |
WG 17 Mechanical hazards |
|
|
| IEC |
TC 062 Electrical equipment in medical practice |
SC 62A Common aspects of electrical equipment used in
medical practice |
WG 18 Overheating, fire protection and additional hazards
|
|
| PRIMARY: RAY L WALCHLE,
(CDRH, OSEL) | |
IEC
|
TC 062 Electrical equipment in medical practice |
SC 62A Common Aspects of Electrical Equipment Used in
Medical Practice |
WG 22 Safety of computer systems used in medical
electrical equipment |
|
| ALTERNATE: PAUL L
JONES, (CDRH, OSEL) |
| PRIMARY: JOANNA H
WEITERSHAUSEN, (CDRH, ODE) | |
IEC
|
TC 062 Electrical equipment in medical practice |
SC 62B Diagnostic imaging equipment |
|
|
| PRIMARY: KISHALAYA
CHAKRABARTI, (CDRH, OCER) |
| ALTERNATE: ROBERT A
PHILLIPS, (CDRH, ODE) | |
IEC
|
TC 062 Electrical equipment in medical practice |
SC 62B Diagnostic imaging equipment |
|
MT 30 Computed tomography |
| ALTERNATE: IACOVOS S
KYPRIANOU, (CDRH, OSEL) |
| PRIMARY: STANLEY H
STERN, (CDRH, OCER) | |
| IEC |
TC 062 Electrical equipment in medical practice |
SC 62B Diagnostic imaging equipment |
|
MT 31 Mammographic X-ray equipment |
| PRIMARY: KISHALAYA
CHAKRABARTI, (CDRH, OCER) |
| ALTERNATE: RICHARD V
KACZMAREK, (CDRH, OCER) | |
| IEC |
TC 062 Electrical equipment in medical practice |
SC 62B Diagnostic imaging equipment |
|
MT 32 Requirements for X-ray source assemblies |
|
IEC
|
TC 062 Electrical equipment in medical practice |
SC 62B Diagnostic imaging equipment |
|
MT 34 Revision of 60601-2-37: Medical electric equipment -
Part 2-37: Particular requirements for the safety of ultrasonic medical
diagnostic.... |
| PRIMARY: BRUCE A
HERMAN, (CDRH, OSEL) | |
| IEC |
TC 062 Electrical equipment in medical practice |
SC 62B Diagnostic imaging equipment |
|
MT 37 IEC 60601-1-3 Ed.2 Medical electrical equipment -
Part 1-3: General requirements for radiation protection in diagnostic
X-ray equipment |
| PRIMARY: RICHARD V
KACZMAREK, (CDRH, OCER) |
| ALTERNATE: ROBERT A
PHILLIPS, (CDRH, ODE) | |
| IEC |
TC 062 Electrical equipment in medical practice |
SC 62B Diagnostic imaging equipment |
|
MT 38 Revision of IEC 61223-3-1 and IEC 61223-3-3 |
| PRIMARY: RICHARD V
KACZMAREK, (CDRH, OCER) | |
IEC
|
TC 062 Electrical equipment in medical practice |
SC 62B Diagnostic imaging equipment |
|
MT 40 Magnetic resonance equipment for medical diagnosis
|
| PRIMARY: WOLFGANG
KAINZ, (CDRH, OSEL) |
| ALTERNATE: SUNDER S
RAJAN, (CDRH, ODE) | |
| IEC |
TC 062 Electrical equipment in medical practice |
SC 62B Diagnostic imaging equipment |
WG 35 IEC 62312-1: Magnetic resonance equipment for
diagnostic imaging - Determination of characteristics - Part 1 |
|
| ALTERNATE: WOLFGANG
KAINZ, (CDRH, OSEL) |
| PRIMARY: SUNDER S
RAJAN, (CDRH, ODE) | |
IEC
|
TC 062 Electrical equipment in medical practice |
SC 62B Diagnostic imaging equipment |
WG 36 Image display devices |
|
| PRIMARY: ALDO BADANO,
(CDRH, OSEL) |
| ALTERNATE: KISHALAYA
CHAKRABARTI, (CDRH, OCER) | |
IEC
|
TC 062 Electrical equipment in medical practice |
SC 62C Equipment for radiotherapy, nuclear medicine and
radiation dosimetry |
WG 01 Beam teletherapy and particle accelerators |
|
| PRIMARY: GAMAL
AKABANI, (CDRH, ODE) |
| ALTERNATE: KISHALAYA
CHAKRABARTI, (CDRH, OCER) | |
| IEC |
TC 062 Electrical equipment in medical practice |
SC 62C Equipment for radiotherapy, nuclear medicine and
radiation dosimetry |
WG 02 Nuclear medicine instrumentation |
|
| ALTERNATE: SIMKEON A
KANG, (CDRH, ODE) | |
IEC
|
TC 062 Electrical equipment in medical practice |
SC 62C Equipment for radiotherapy, nuclear medicine and
radiation dosimetry |
WG 03 Performance of dosimeters |
|
| PRIMARY: GAMAL
AKABANI, (CDRH, ODE) | |
IEC
|
TC 062 Electrical equipment in medical practice |
SC 62D Electromedical equipment |
|
|
| ALTERNATE: GEMA
GONZALEZ, (CDRH, ODE) |
| PRIMARY: NANCY A
PRESSLY, (CDRH, OSB) | |
IEC
|
TC 062 Electrical equipment in medical practice |
SC 62D Electromedical equipment |
|
MT 17 High frequency surgical equipment |
| ALTERNATE: LONG H CHEN,
(CDRH, ODE) |
| PRIMARY: ROXOLANA I
HORBOWYJ, (CDRH, ODE) | |
| IEC |
TC 062 Electrical equipment in medical practice |
SC 62D Electromedical Equipment |
|
MT 18 Requirements for Therapy equipment, 60601-2-10 Nerve
and Muscle Stimulators |
| PRIMARY: ROBERT J DE
LUCA, (CDRH, ODE) | |
IEC
|
TC 062 Electrical equipment in medical practice |
SC 62D Electromedical equipment |
|
MT 18 Therapy equipment |
| PRIMARY: GERALD R
HARRIS, (CDRH, OSEL) | |
| IEC |
TC 062 Electrical equipment in medical practice |
SC 62D Electromedical Equipment |
|
MT 19 Requirements for Defibrillators |
| PRIMARY: CAROLE C
CAREY, (CDRH, ODE) | |
IEC
|
TC 062 Electrical equipment in medical practice |
SC 62D Electromedical equipment |
|
MT 20 Hemodialysis equipment |
| PRIMARY: GEMA
GONZALEZ, (CDRH, ODE) | |
IEC
|
TC 062 Electrical equipment in medical practice |
SC 62D Electromedical equipment |
|
MT 21 Paediatric equipment |
| ALTERNATE: WILLIAM M
BURDICK, (CDRH, ODE) |
| PRIMARY: NANCY A
PRESSLY, (CDRH, OSB) | |
| IEC |
TC 062 Electrical equipment in medical practice |
SC 62D Electromedical equipment |
|
MT 23 Infusion pumps |
| PRIMARY: ALAN M
STEVENS, (CDRH, OC) | |
| IEC |
TC 062 Electrical equipment in medical practice |
SC 62D Electromedical equipment |
|
MT 24 Extra-corporeal lithotripsy equipment |
| PRIMARY: GERALD R
HARRIS, (CDRH, OSEL) | |
IEC
|
TC 062 Electrical equipment in medical practice |
SC 62D Electromedical equipment |
|
MT 25 Hospital beds |
| PRIMARY: JOAN FERLO
TODD, (CDRH, OSB) |
| ALTERNATE: MATTHEW J
POWERS, (CDRH, OC) | |
| IEC |
TC 062 Electrical equipment in medical practice |
SC 62D Electromedical equipment |
|
MT 27 Luminaires for surgery and diagnosis |
|
| IEC |
TC 065 Industrial Process Measurement and Control |
SC 65A Systems Aspects |
WG 10 Functional safety of programmable electronic systems
|
MT 01 Software System Safety Requirements |
| PRIMARY: PAUL L JONES,
(CDRH, OSEL) | |
| IEC |
TC 065 Industrial Process Measurement and Control |
SC 65A Systems Aspects |
WG 10 Functional safety of programmable electronic systems
|
MT 02 General System Safety Requirements |
| PRIMARY: PAUL L JONES,
(CDRH, OSEL) | |
IEC
|
TC 076 Optical radiation safety and laser equipment |
|
|
|
| PRIMARY: ROBERT W
FAALAND, (CDRH, OSEL) |
| ALTERNATE: DANIEL J
HEWETT, (CDRH, OCER) | |
| IEC |
TC 076 Optical radiation safety and laser equipment |
|
WG 01 Optical radiation safety |
|
| PRIMARY: ROBERT W
FAALAND, (CDRH, OSEL) |
| ALTERNATE: DANIEL J
HEWETT, (CDRH, OCER) | |
| IEC |
TC 076 Optical radiation safety and laser equipment |
|
WG 03 Laser radiation measurement |
|
| PRIMARY: ROBERT W
FAALAND, (CDRH, OSEL) |
| ALTERNATE: DANIEL J
HEWETT, (CDRH, OCER) | |
| IEC |
TC 076 Optical radiation safety and laser equipment |
|
WG 04 Safety of medical laser equipment |
|
| PRIMARY: ROBERT W
FAALAND, (CDRH, OSEL) |
| ALTERNATE: DANIEL J
HEWETT, (CDRH, OCER) | |
| IEC |
TC 076 Optical radiation safety and laser equipment |
|
WG 05 Safety of fibre optics communications systems |
|
| PRIMARY: ROBERT W
FAALAND, (CDRH, OSEL) |
| ALTERNATE: DANIEL J
HEWETT, (CDRH, OCER) | |
| IEC |
TC 076 Optical radiation safety and laser equipment |
|
WG 07 High power lasers |
|
| PRIMARY: ROBERT W
FAALAND, (CDRH, OSEL) |
| ALTERNATE: DANIEL J
HEWETT, (CDRH, OCER) | |
| IEC |
TC 076 Optical radiation safety and laser equipment |
|
WG 08 Development and maintenance of basic standards |
|
| PRIMARY: ROBERT W
FAALAND, (CDRH, OSEL) |
| ALTERNATE: DANIEL J
HEWETT, (CDRH, OCER) | |
| IEC |
TC 076 Optical radiation safety and laser equipment |
|
WG 09 Non coherent sources |
|
| PRIMARY: ROBERT W
FAALAND, (CDRH, OSEL) |
| ALTERNATE: DANIEL J
HEWETT, (CDRH, OCER) | |
| IEC |
TC 076 Optical radiation safety and laser equipment |
|
WG 10 Safety of lasers and laser equipment in an
industrial materials processing environment (JWG w/ISO TC 172/SC9 |
|
| PRIMARY: ROBERT W
FAALAND, (CDRH, OSEL) |
| ALTERNATE: DANIEL J
HEWETT, (CDRH, OCER) | |
IEC
|
TC 077 Electromagnetic compatibility |
|
|
|
| PRIMARY: JEFFREY L
SILBERBERG, (CDRH, OSEL) | |
| IEC |
TC 087 Ultrasonics |
|
WG 08 Ultrasonic field measurement |
|
| ALTERNATE: GERALD R
HARRIS, (CDRH, OSEL) |
| PRIMARY: BRUCE A
HERMAN, (CDRH, OSEL) | |
| IEC |
TC 087 Ultrasonics |
|
WG 09 Pulse-Echo Diagnostic Equipment |
|
| PRIMARY: KEITH A WEAR,
(CDRH, OSEL) | |
| IEC |
TC 087 Ultrasonics |
|
WG 12 Ultrasound exposure parameters |
|
| ALTERNATE: BRUCE A
HERMAN, (CDRH, OSEL) |
| PRIMARY: MELVIN E
STRATMEYER, (CDRH, OSEL) | |
| IEC |
TC 106 Methods for the assessment of electric, magnetic
and electromagnetic fields associated with human exposure |
|
|
|
|
| IEC |
U. S. Coordinating committee on electromagnetic
compatibility |
|
|
|
| PRIMARY: JEFFREY L
SILBERBERG, (CDRH, OSEL) | |
| IEC |
U.S. Safety Coordinating Committee (USSCC) |
|
|
|
| PRIMARY: JEROME E
DENNIS, (CDRH, OC) | |
IEEE
|
International Committee on Electromagnetic Safety (ICES)
TC215 |
|
IEEE 1073/ISO TC215/CEN TC 251 Joint Working Group for
medical device communication and data exchange systems |
|
| PRIMARY: JAMES CHENG,
(CDRH, ODE) |
| ALTERNATE: DONALD M WITTERS
JR, (CDRH, OSEL) | |
| IEEE |
International Committee on Electromagnetic Safety (ICES)
TC34 |
SC2 Wireless Handset SAR Certification |
WG1 Experimental Techniques |
|
| ALTERNATE: ISAAC A
CHANG, (CDRH, OSEL) |
| PRIMARY: WOLFGANG
KAINZ, (CDRH, OSEL) | |
| IEEE |
International Committee on Electromagnetic Safety (ICES)
TC34 |
SC2 Wireless Handset SAR Certification |
WG2 Computational Techniques |
|
| ALTERNATE: ISAAC A
CHANG, (CDRH, OSEL) |
| PRIMARY: WOLFGANG
KAINZ, (CDRH, OSEL) | |
| IEEE |
International Committee on Electromagnetic Safety (ICES)
TC95 |
Executive Committee |
|
|
| PRIMARY: HOWARD I
BASSEN, (CDRH, OSEL) | |
| IEEE |
International Committee on Electromagnetic Safety (ICES)
TC95 |
SC1 Measurements and computation |
|
|
| PRIMARY: HOWARD I
BASSEN, (CDRH, OSEL) | |
| IEEE |
International Committee on Electromagnetic Safety (ICES)
TC95 |
SC3 Safety levels to human exposure 0-3kHz |
|
|
| PRIMARY: HOWARD I
BASSEN, (CDRH, OSEL) | |
| IEEE |
International Committee on Electromagnetic Safety (ICES)
TC95 |
SC4 Safety levels to human exposure 3kHz-300GHz |
|
|
| PRIMARY: HOWARD I
BASSEN, (CDRH, OSEL) | |
| ISAC |
Clinical and Regulatory Affairs Committee |
|
|
|
| PRIMARY: LOUISE E
MAGRUDER, (CDRH, OIVD) | |
| ISBT |
Automation and Data Processing Working Group |
|
|
|
| PRIMARY: JOSEPH JORGENS
III, (CDRH, OSEL) | |
| ISCVS |
Endovascular Graft (EVG) Study Committee (Joint effort
with Society for Vascular Surgery) |
|
|
|
| PRIMARY: DOROTHY B
ABEL, (CDRH, ODE) | |
ISO
|
TC 76 Transfusion, infusion and injection equipment for
medical and pharmaceutical use |
|
|
|
| PRIMARY: NINA C
MEZU-NWABA, (CDRH, ODE) | |
ISO
|
TC 84 Devices for administration of medicinal products and
intravascular catheters |
|
WG 03 Insulin syringes and pen injectors for drugs |
|
| ALTERNATE: MARY E
BROOKS, (CDRH, ODE) |
| PRIMARY: NINA C
MEZU-NWABA, (CDRH, ODE) | |
| ISO |
TC 84 Devices for administration of medicinal products and
intravascular catheters |
|
WG 04 Needle-free injectors |
|
| PRIMARY: LANA L SHIU,
(CDRH, ODE) |
| ALTERNATE: PANDU R
SOPREY, (CDRH, ODE) | |
ISO
|
TC 84 Devices for administration of medicinal products and
intravascular catheters |
|
WG 05 Joint TC 84 - TC 76 - TC 121/SC 03 WG: Pulmonary
devices |
|
| ALTERNATE: MICHAEL J
HUSBAND, (CDRH, ODE) |
| PRIMARY: WILLIAM C
MALONEY, (CDRH, OC) | |
ISO
|
TC 84 Devices for administration of medicinal products and
intravascular catheters |
|
WG 06 Auto-injectors |
|
| ALTERNATE: ELSBETH G
CHIKHALE, (CDER, OPS) |
| PRIMARY: ANTHONY D
WATSON, (CDRH, ODE) | |
ISO
|
TC 84 Devices for administration of medicinal products and
intravascular catheters |
|
WG 07 Safety issues for needles |
|
| ALTERNATE: MARY E
BROOKS, (CDRH, ODE) |
| PRIMARY: SCOTT A
COLBURN, (CDRH, ODE) | |
ISO
|
TC 84 Devices for administration of medicinal products and
intravascular catheters |
SC 01 Syringes, needles and intravascular catheters for
single use |
WG 01 Sterile, single use, intravascular catheters |
|
| PRIMARY: SCOTT A
COLBURN, (CDRH, ODE) |
| ALTERNATE: ANTHONY D
WATSON, (CDRH, ODE) | |
| ISO |
TC 069 Applications of statistical methods |
SC4 Applications of Statistical Methods in Process
Management |
|
|
|
| ISO |
TC 106 Dentistry |
|
WG 10 Biological evaluation |
|
| ALTERNATE: MICHAEL J
RYAN, (CDRH, ODE) | |
| ISO |
TC 106 Dentistry |
SC 01 Filling and restorative materials |
|
|
| ALTERNATE: VASANT G
MALSHET, (CDRH, ODE) |
| PRIMARY: KEVIN P MULRY,
(CDRH, ODE) | |
| ISO |
TC 106 Dentistry |
SC 02 Prosthodontic materials |
|
|
| ALTERNATE: MICHAEL E
ADJODHA, (CDRH, ODE) | |
| ISO |
TC 106 Dentistry |
SC 03 Terminology |
|
|
| PRIMARY: ROBERT S BETZ,
(CDRH, ODE) | |
| ISO |
TC 106 Dentistry |
SC 04 Dental instruments |
|
|
| ALTERNATE: MICHAEL
MENDELSON, (CDRH, OCER) |
| PRIMARY: MICHAEL J
RYAN, (CDRH, ODE) | |
| ISO |
TC 106 Dentistry |
SC 06 Dental equipment |
|
|
| PRIMARY: KEVIN P MULRY,
(CDRH, ODE) |
| ALTERNATE: MICHAEL J
RYAN, (CDRH, ODE) | |
ISO
|
TC 106 Dentistry |
SC 08 Dental implants |
|
|
| PRIMARY: MICHAEL J
RYAN, (CDRH, ODE) | |
ISO
|
TC 121 Anaesthetic and respiratory equipment |
SC 01 Breathing attachments and anaesthetic machines |
|
|
| PRIMARY: KIMBERLY G
LOVE, (CDRH, ODE) | |
ISO
|
TC 121 Anaesthetic and respiratory equipment |
SC 02 Tracheal tubes and other equipment |
|
|
| ALTERNATE: ROBERT A
FISCHER, (CDRH, OSB) |
| PRIMARY: WILLIAM C
MALONEY, (CDRH, OC) | |
ISO
|
TC 121 Anaesthetic and respiratory equipment |
SC 03 Lung ventilators and related equipment |
|
|
| PRIMARY: MELANIE CHOE,
(CDRH, ODE) |
| ALTERNATE: JENNIFER R
MEDICUS, (CDRH, OC) | |
ISO
|
TC 150 Implants for surgery |
|
|
|
| ALTERNATE: JOHN S
GOODE, (CDRH, ODE) |
| PRIMARY: MARK N
MELKERSON, (CDRH, ODE) | |
| ISO |
TC 150 Implants for surgery |
|
WG 05 Retrieval and analysis of implants |
|
| ALTERNATE: DONALD E
MARLOWE, (OC, OSHC) | |
ISO
|
TC 150 Implants for surgery |
SC 01 Materials |
|
|
| PRIMARY: HANY W DEMIAN,
(CDRH, ODE) |
| ALTERNATE: AUBREY D GANTT
JR, (CDRH, ODE) |
| ALTERNATE: JOHN S
GOODE, (CDRH, ODE) |
| ALTERNATE: TERRY O
WOODS, (CDRH, OSEL) | |
ISO
|
TC 150 Implants for surgery |
SC 02 Cardiovascular implants and extracorporeal systems
|
|
|
| PRIMARY: DOROTHY B
ABEL, (CDRH, ODE) | |
| ISO |
TC 150 Implants for surgery |
SC 02 Cardiovascular implants and extracorporeal systems
|
WG 01 Cardiac valves |
|
| PRIMARY: SANDY F
STEWART, (CDRH, OSEL) | |
ISO
|
TC 150 Implants for surgery |
SC 02 Cardiovascular implants and extracorporeal systems
|
WG 03 Vascular prostheses |
|
| PRIMARY: DOROTHY B
ABEL, (CDRH, ODE) |
| ALTERNATE: JENNIFER L
GOODE, (CDRH, ODE) |
| ALTERNATE: ANGELA C
SMITH, (CDRH, ODE) | |
ISO
|
TC 150 Implants for surgery |
SC 02 Cardiovascular implants and extracorporeal systems
|
WG 04 Blood gas exchangers |
|
| PRIMARY: ARTHUR A
CIARKOWSKI, (CDRH, ODE) |
| ALTERNATE: RONALD A
ROBINSON, (CDRH, OSEL) | |
ISO
|
TC 150 Implants for surgery |
SC 02 Cardiovascular implants and extracorporeal systems
|
WG 05 Renal replacement, detoxification and apheresis |
|
| PRIMARY: GEMA
GONZALEZ, (CDRH, ODE) | |
| ISO |
TC 150 Implants for surgery |
SC 02 Cardiovascular implants and extracorporeal systems
|
WG 06 Vascular device/drug combination products |
|
| PRIMARY: JENNIFER L
GOODE, (CDRH, ODE) |
| ALTERNATE: HINA M
PINTO, (CDRH, ODE) | |
| ISO |
TC 150 Implants for surgery |
SC 03 Neurosurgical implants |
|
|
| PRIMARY: JEAN E
RINALDI, (CDRH, OSEL) |
| ALTERNATE: TERRY O
WOODS, (CDRH, OSEL) | |
ISO
|
TC 150 Implants for surgery |
SC 04 Bone and joint replacements |
|
|
| ALTERNATE: HANY W
DEMIAN, (CDRH, ODE) |
| PRIMARY: JOHN S GOODE,
(CDRH, ODE) | |
ISO
|
TC 150 Implants for surgery |
SC 04 Bone and joint replacements |
WG 01 Mechanical testing of components |
|
| ALTERNATE: HANY W
DEMIAN, (CDRH, ODE) |
| PRIMARY: JOHN S GOODE,
(CDRH, ODE) | |
ISO
|
TC 150 Implants for surgery |
SC 05 Osteosynthesis and spinal devices |
|
|
| ALTERNATE: JODI HOPE N
ANDERSON, (CDRH, ODE) |
| PRIMARY: JONATHAN H
PECK, (CDRH, ODE) | |
| ISO |
TC 150 Implants for surgery |
SC 05 Osteosynthesis and spinal devices |
WG 02 Spinal devices |
|
| ALTERNATE: JODI HOPE N
ANDERSON, (CDRH, ODE) |
| PRIMARY: JONATHAN H
PECK, (CDRH, ODE) | |
ISO
|
TC 150 Implants for surgery |
SC 06 Active implants |
|
|
| ALTERNATE: VICTOR
KRAUTHAMMER, (CDRH, OSEL) |
| PRIMARY: MITCHELL J
SHEIN, (CDRH, ODE) | |
| ISO |
TC 150 Implants for surgery |
SC 06 Active implants |
WG 03, Cochlear implants |
|
| TECH EXPERT: BRIAN B
BEARD, (CDRH, OSEL) |
| PRIMARY: JAMES K KANE,
(CDRH, ODE) |
| TECH EXPERT: VICTOR
KRAUTHAMMER, (CDRH, OSEL) |
| ALTERNATE: SRINIVAS
NANDKUMAR, (CDRH, ODE) | |
ISO
|
TC 150 Implants for surgery |
SC 06 Active implants |
WG 04 Implantable infusion pumps |
|
| PRIMARY: ALAN M
STEVENS, (CDRH, OC) | |
ISO
|
TC 150 Implants for surgery |
SC 06 Active implants |
WG 05 Implantable neurostimulators |
|
| PRIMARY: STEPHEN M
HINCKLEY, (CDRH, ODE) |
| ALTERNATE: VICTOR
KRAUTHAMMER, (CDRH, OSEL) | |
| ISO |
TC 150 Implants for surgery |
SC 06 Active Implants |
WG 06 Circulatory support devices |
|
| PRIMARY: MICHAEL R
BERMAN, (CDRH, OSEL) |
| ALTERNATE: JEAN E
RINALDI, (CDRH, OSEL) | |
ISO
|
TC 150 Implants for surgery |
SC 7 Tissue Engineered Medical Products |
|
|
| PRIMARY: DAVID S
KAPLAN, (CDRH, OSEL) |
| ALTERNATE: CELIA M
WITTEN, (CBER, OCTGT) | |
ISO
|
TC 157 Mechanical contraceptives |
|
|
|
| PRIMARY: COLIN M
POLLARD, (CDRH, ODE) | |
| ISO |
TC 157 Mechanical contraceptives |
|
WG 10 Minimum burst pressure and burst volume requirements
|
|
| PRIMARY: COLIN M
POLLARD, (CDRH, ODE) | |
| ISO |
TC 157 Mechanical contraceptives |
|
WG 11 Packaging integrity |
|
| PRIMARY: COLIN M
POLLARD, (CDRH, ODE) | |
| ISO |
TC 157 Mechanical contraceptives |
|
WG 12 Determination of the amount of lubricant |
|
| PRIMARY: COLIN M
POLLARD, (CDRH, ODE) | |
| ISO |
TC 157 Mechanical contraceptives |
|
WG 13 Stability assessment |
|
| PRIMARY: COLIN M
POLLARD, (CDRH, ODE) | |
| ISO |
TC 157 Mechanical contraceptives |
|
WG 14 Guidance on the use of ISO 4074 |
|
| PRIMARY: COLIN M
POLLARD, (CDRH, ODE) | |
| ISO |
TC 157 Mechanical contraceptives |
|
WG 15 Test methods for the effect of additional lubricants
on physical properties of condoms |
|
| PRIMARY: ELAINE H
BLYSKUN, (CDRH, ODE) |
| ALTERNATE: DONNA L
WALSH, (CDRH, OSEL) | |
| ISO |
TC 157 Mechanical contraceptives |
|
WG 17 Synthetic condoms |
|
| ALTERNATE: LESLEY N
KERR, (ORA, NE-FO) |
| PRIMARY: COLIN M
POLLARD, (CDRH, ODE) | |
| ISO |
TC 157 Mechanical contraceptives |
|
WG 18 Female condoms |
|
| ALTERNATE: LESLEY N
KERR, (ORA, NE-FO) |
| PRIMARY: JOSEPH C
TEIXEIRA, (ORA, NE-FO) | |
| ISO |
TC 157 Mechanical contraceptives |
|
WG 19 Methods for hole detection |
|
| ALTERNATE: LESLEY N
KERR, (ORA, NE-FO) |
| PRIMARY: JOSEPH C
TEIXEIRA, (ORA, NE-FO) | |
| ISO |
TC 157 Mechanical contraceptives |
|
WG 20 Clinical trials |
|
| ALTERNATE: RICHARD M
KOTZ, (CDRH, OSB) |
| PRIMARY: COLIN M
POLLARD, (CDRH, ODE) | |
| ISO |
TC 172 Optics and photonics |
|
|
|
| ALTERNATE: ROBERT H
JAMES, (CDRH, OSEL) |
| PRIMARY: SHARON A
MILLER, (CDRH, OSEL) | |
ISO
|
TC 172 Optics and photonics |
SC 5 Microscopes and endoscopes |
WG 6 Endoscopes |
|
| PRIMARY: MARY JOAN
CORNELIUS, (CDRH, ODE) |
| ALTERNATE: SHARON A
MILLER, (CDRH, OSEL) | |
| ISO |
TC 172 Optics and photonics |
SC 7 Ophthalmic optics and instruments |
|
|
| PRIMARY: SHARON A
MILLER, (CDRH, OSEL) |
| ALTERNATE: DEXIU SHI,
(CDRH, ODE) | |
| ISO |
TC 172 Optics and photonics |
SC 7 Ophthalmic optics and instruments |
WG 1 Terminology |
|
| PRIMARY: ROBERT H
JAMES, (CDRH, OSEL) | |
| ISO |
TC 172 Optics and photonics |
SC 7 Ophthalmic optics and instruments |
WG 2 Spectacle frames |
|
|
| ISO |
TC 172 Optics and photonics |
SC 7 Ophthalmic optics and instruments |
WG 3 Spectacle lenses |
|
|
| ISO |
TC 172 Optics and photonics |
SC 7 Ophthalmic optics and instruments |
WG 6 Ophthalmic instruments and test methods |
|
| ALTERNATE: EVERETTE T
BEERS, (CDRH, ODE) |
| TECH EXPERT: BRUCE A
DRUM, (CDRH, ODE) |
| TECH EXPERT: GENE N
HILMANTEL, (CDRH, ODE) |
| TECH EXPERT: BERNARD P
LEPRI, (CDRH, ODE) |
| PRIMARY: SHARON A
MILLER, (CDRH, OSEL) | |
| ISO |
TC 172 Optics and photonics |
SC 7 Ophthalmic optics and instruments |
WG 7 Ophthalmic implants |
|
| TECH EXPERT: KESIA Y
ALEXANDER, (CDRH, ODE) |
| TECH EXPERT: EVERETTE T
BEERS, (CDRH, ODE) |
| TECH EXPERT: SHERYL L
BERMAN, (CDRH, ODE) |
| PRIMARY: DON CALOGERO,
(CDRH, ODE) |
| TECH EXPERT: BRUCE A
DRUM, (CDRH, ODE) |
| TECH EXPERT: MALVINA B
EYDELMAN, (CDRH, ODE) |
| ALTERNATE: ROBERT W
FAALAND, (CDRH, OSEL) |
| TECH EXPERT: GENE N
HILMANTEL, (CDRH, ODE) |
| TECH EXPERT: BERNARD P
LEPRI, (CDRH, ODE) |
| TECH EXPERT: SHARON A
MILLER, (CDRH, OSEL) |
| TECH EXPERT: EVA M
RORER, (CDRH, ODE) |
| TECH EXPERT: MING CHUEN
SHIH, (CDRH, ODE) | |
| ISO |
TC 172 Optics and photonics |
SC 7 Ophthalmic optics and instruments |
WG 8 Data interchange |
|
|
| ISO |
TC 172 Optics and photonics |
SC 7 Ophthalmic optics and instruments |
WG 9 Contact lenses |
|
| TECH EXPERT: CHANDRAMAL
GHOSH, (CDRH, ODE) |
| ALTERNATE: GENE N
HILMANTEL, (CDRH, ODE) |
| TECH EXPERT: JOSEPH C
HUTTER, (CDRH, OSEL) |
| TECH EXPERT: BERNARD P
LEPRI, (CDRH, ODE) |
| TECH EXPERT: MARC
ROBBOY, (CDRH, ODE) |
| TECH EXPERT: JAMES F
SAVIOLA, (CDRH, ODE) |
| TECH EXPERT: MYRA K
SMITH, (CDRH, ODE) |
| PRIMARY: KAREN F
WARBURTON, (CDRH, ODE) | |
ISO
|
TC 172 Optics and photonics |
SC 9 Electro-optical systems |
|
|
| PRIMARY: ROBERT W
FAALAND, (CDRH, OSEL) |
| ALTERNATE: ROBERT H
JAMES, (CDRH, OSEL) | |
ISO
|
TC 172 Optics and photonics |
SC 9 Electro-optical systems |
WG 1 Terminology and test methods for lasers |
|
| PRIMARY: ROBERT W
FAALAND, (CDRH, OSEL) |
| ALTERNATE: DEXIU SHI,
(CDRH, ODE) | |
| ISO |
TC 172 Optics and photonics |
SC 9 Electro-optical systems |
WG 2 Interfaces and system specifications for lasers |
|
| PRIMARY: ROBERT W
FAALAND, (CDRH, OSEL) | |
ISO
|
TC 172 Optics and photonics |
SC 9 Electro-optical systems |
WG 3 Safety |
|
| PRIMARY: ROBERT W
FAALAND, (CDRH, OSEL) |
| ALTERNATE: DEXIU SHI,
(CDRH, ODE) | |
| ISO |
TC 172 Optics and photonics |
SC 9 Electro-optical systems |
WG 4 Laser systems for medical applications |
|
| PRIMARY: ROBERT W
FAALAND, (CDRH, OSEL) |
| ALTERNATE: DEXIU SHI,
(CDRH, ODE) | |
| ISO |
TC 172 Optics and photonics |
SC 9 Electro-optical systems |
WG 5 Laser systems for general applications |
|
| PRIMARY: ROBERT W
FAALAND, (CDRH, OSEL) |
| ALTERNATE: ROBERT H
JAMES, (CDRH, OSEL) | |
| ISO |
TC 172 Optics and photonics |
SC 9 Electro-optical systems |
WG 6 Optical components and their test methods |
|
| PRIMARY: ROBERT W
FAALAND, (CDRH, OSEL) |
| ALTERNATE: DEXIU SHI,
(CDRH, ODE) | |
| ISO |
TC 172 Optics and photonics |
SC 9 Electro-optical systems |
WG 7 Electro-optical systems other than lasers |
|
| PRIMARY: ROBERT W
FAALAND, (CDRH, OSEL) |
| ALTERNATE: ROBERT H
JAMES, (CDRH, OSEL) | |
| ISO |
TC 173 Assistive products for persons with disability |
SC 3 Aids for ostomy and incontinence |
|
|
|
| ISO |
TC 173 Assistive products for persons with disability
(RESNA) |
|
|
|
| ALTERNATE: MATTHEW R
SCHWERIN, (CDRH, OSEL) |
| PRIMARY: AMY M
SKRZYPCHAK, (CDRH, OC) | |
ISO
|
TC 173 Assistive products for persons with disability
(RESNA) |
SC 1 Wheelchairs |
|
|
| ALTERNATE: MATTHEW R
SCHWERIN, (CDRH, OSEL) |
| PRIMARY: AMY M
SKRZYPCHAK, (CDRH, OC) | |
| ISO |
TC 173 Assistive products for persons with disability
(RESNA) |
SC 1 Wheelchairs |
WG 1 Test methods |
|
| ALTERNATE: MATTHEW R
SCHWERIN, (CDRH, OSEL) |
| PRIMARY: AMY M
SKRZYPCHAK, (CDRH, OC) | |
ISO
|
TC 173 Assistive products for persons with disability
(RESNA) |
SC 1 Wheelchairs |
WG 10 Requirements and test methods for electro-technical
systems for wheelchairs |
|
| ALTERNATE: MATTHEW R
SCHWERIN, (CDRH, OSEL) |
| PRIMARY: DONALD M WITTERS
JR, (CDRH, OSEL) | |
ISO
|
TC 176 Quality management and quality assurance |
|
|
|
| PRIMARY: KIMBERLY A
TRAUTMAN, (CDRH, OC) |
| ALTERNATE: JAN WELCH,
(CDRH, OC) | |
ISO
|
TC 194 Biological evaluation of medical devices |
|
|
|
| ALTERNATE: DONALD E
MARLOWE, (OC, OSHC) |
| PRIMARY: MELVIN E
STRATMEYER, (CDRH, OSEL) | |
| ISO |
TC 194 Biological evaluation of medical devices |
|
WG 01 Systematic approach to biological evaluation and
terminology |
|
| PRIMARY: JENNIFER L
GOODE, (CDRH, ODE) |
| ALTERNATE: MELVIN E
STRATMEYER, (CDRH, OSEL) | |
ISO
|
TC 194 Biological evaluation of medical devices |
|
WG 02 Degradation aspects related to biological testing
|
|
| ALTERNATE: AUBREY D GANTT
JR, (CDRH, ODE) |
| PRIMARY: SCOTT G
MCNAMEE, (CDRH, OC) | |
| ISO |
TC 194 Biological evaluation of medical devices |
|
WG 03 Animal protection aspects |
|
| PRIMARY: MELVIN E
STRATMEYER, (CDRH, OSEL) | |
ISO
|
TC 194 Biological evaluation of medical devices |
|
WG 04 Clinical investigation of medical devices in humans
|
|
| PRIMARY: KIMBER C
RICHTER, (CDRH, OC) |
| ALTERNATE: MARIAN J
SERGE, (CDRH, OC) | |
| ISO |
TC 194 Biological evaluation of medical devices |
|
WG 05 Cytotoxicity |
|
| PRIMARY: VICTORIA M
HITCHINS, (CDRH, OSEL) |
| ALTERNATE: JEFFREY
TOY, (CDRH, ODE) | |
ISO
|
TC 194 Biological evaluation of medical devices |
|
WG 06 Mutagenicity, carcinogenicity and reproductive
toxicity |
|
| ALTERNATE: RAMESH
PANGULURI, (CDRH, ODE) |
| PRIMARY: JEFFREY TOY,
(CDRH, ODE) | |
| ISO |
TC 194 Biological evaluation of medical devices |
|
WG 07 Systemic toxicity |
|
| ALTERNATE: RONALD P
BROWN, (CDRH, OSEL) |
| PRIMARY: MELVIN E
STRATMEYER, (CDRH, OSEL) | |
ISO
|
TC 194 Biological evaluation of medical devices |
|
WG 08 Irritation, sensitization |
|
| PRIMARY: VASANT G
MALSHET, (CDRH, ODE) |
| ALTERNATE: MRIDULIKA
VIRMANI, (CDRH, ODE) | |
| ISO |
TC 194 Biological evaluation of medical devices |
|
WG 09 Effects on blood |
|
| PRIMARY: JENNIFER L
GOODE, (CDRH, ODE) |
| ALTERNATE: WILLIAM G
LETZING, (CDRH, ODE) | |
| ISO |
TC 194 Biological evaluation of medical devices |
|
WG 10 Implantation |
|
| PRIMARY: VASANT G
MALSHET, (CDRH, ODE) |
| ALTERNATE: JEFFREY
TOY, (CDRH, ODE) | |
| ISO |
TC 194 Biological evaluation of medical devices |
|
WG 11 Allowable limits of leachable substances |
|
| PRIMARY: RONALD P
BROWN, (CDRH, OSEL) |
| ALTERNATE: MELVIN E
STRATMEYER, (CDRH, OSEL) | |
ISO
|
TC 194 Biological evaluation of medical devices |
|
WG 12 Sample preparation and reference materials |
|
| ALTERNATE: KAREEM S
BURNEY, (CDRH, ODE) |
| PRIMARY: DONALD E
MARLOWE, (OC, OSHC) | |
| ISO |
TC 194 Biological evaluation of medical devices |
|
WG 13 Toxicokinetic study |
|
| ALTERNATE: RONALD P
BROWN, (CDRH, OSEL) |
| PRIMARY: HOAN MY D LUU,
(CDRH, OSEL) | |
| ISO |
TC 194 Biological evaluation of medical devices |
|
WG 14 Material characterization |
|
| ALTERNATE: IRADA S
ISAYEVA, (CDRH, OSEL) |
| PRIMARY: STEVEN
POLLACK, (CDRH, OSEL) | |
| ISO |
TC 194 Biological evaluation of medical devices |
|
WG 15 Strategic approach to biological assessment |
|
| ALTERNATE: RONALD P
BROWN, (CDRH, OSEL) |
| PRIMARY: MELVIN E
STRATMEYER, (CDRH, OSEL) | |
| ISO |
TC 194 Biological evaluation of medical devices |
|
WG 16, Pyrogenicity |
|
| PRIMARY: VICTORIA M
HITCHINS, (CDRH, OSEL) | |
ISO
|
TC 194 Biological evaluation of medical devices |
SC 01 Tissue product safety |
WG 01 Risk assessment, terminology and global aspects |
|
| PRIMARY: SCOTT G
MCNAMEE, (CDRH, OC) | |
ISO
|
TC 194 Biological evaluation of medical devices |
SC 01 Tissue product safety |
WG 02 Sourcing controls, collection and handling |
|
| PRIMARY: SCOTT G
MCNAMEE, (CDRH, OC) | |
ISO
|
TC 194 Biological evaluation of medical devices |
SC 01 Tissue product safety |
WG 03 Elimination and / or inactivation of viruses and TSE
agents |
|
| PRIMARY: SCOTT G
MCNAMEE, (CDRH, OC) | |
| ISO |
TC 194 Biological evaluation of medical devices |
SC 01 Tissue product safety |
WG 04 TSE Elimination |
|
| PRIMARY: SCOTT G
MCNAMEE, (CDRH, OC) | |
ISO
|
TC 198 Sterilization Standards Committee |
|
WG 01 Industrial EO sterilization |
|
| ALTERNATE: JOHN M
KUCHINSKI, (CDRH, ODE) |
| PRIMARY: STEVEN E
TURTIL, (CDRH, ODE) | |
ISO
|
TC 198 Sterilization Standards Committee |
|
WG 02 Radiation sterlization |
|
| ALTERNATE: HARRY F
BUSHAR, (CDRH, OSB) |
| ALTERNATE: MARY ANNE
MALARKEY, (CBER, OCBQ) |
| PRIMARY: PATRICK B
WEIXEL, (CDRH, OC) | |
ISO
|
TC 198 Sterilization Standards Committee |
|
WG 03 Industrial moist heat sterilization |
|
| ALTERNATE: GEETHA C
JAYAN, (ODE, DAGID) |
| PRIMARY: ELIZABETH A
RIEGEL, (CDRH, OC) | |
ISO
|
TC 198 Sterilization Standards Committee |
|
WG 04 Biological indicators |
|
| ALTERNATE: CHRISTOPHE A
DEMITRUS, (ORA, NE-FO) |
| PRIMARY: CANDACE
MCMANUS, (CDRH, OC) | |
| ISO |
TC 198 Sterilization Standards Committee |
|
WG 05 Sterilization terminology |
|
| PRIMARY: VICTORIA M
HITCHINS, (CDRH, OSEL) |
| ALTERNATE: SHARON KAY
LAPPALAINEN, (CDRH, ODE) | |
ISO
|
TC 198 Sterilization Standards Committee |
|
WG 06 Chemical indicators |
|
| ALTERNATE: MICHELLE
RIOS, (CDRH, ODE) |
| PRIMARY: JENNIFER L
SCHMIDT, (CDRH, ODE) | |
ISO
|
TC 198 Sterilization Standards Committee |
|
WG 07 Packaging |
|
| PRIMARY: VICTORIA M
HITCHINS, (CDRH, OSEL) |
| ALTERNATE: STEVEN E
TURTIL, (CDRH, ODE) | |
ISO
|
TC 198 Sterilization Standards Committee |
|
WG 08 Microbiological methods |
|
| ALTERNATE: VICTORIA M
HITCHINS, (CDRH, OSEL) |
| ALTERNATE: SHARON KAY
LAPPALAINEN, (CDRH, ODE) | |
ISO
|
TC 198 Sterilization Standards Committee |
|
WG 09 Aseptic processing |
|
| PRIMARY: THOMAS J
ARISTA, (ORA, ORO) |
| ALTERNATE: ELAINE S
MAYHALL, (CDRH, ODE) | |
ISO
|
TC 198 Sterilization Standards Committee |
|
WG 10 Liquid chemical sterlization |
|
| ALTERNATE: KEVIN D
KALLANDER, (ORA, SW-FO) |
| PRIMARY: CANDACE
MCMANUS, (CDRH, OC) | |
| ISO |
TC 198 Sterilization Standards Committee |
|
WG 11 General criteria for sterlization processes |
|
| PRIMARY: CHIU S LIN,
(CDRH, ODE) |
| ALTERNATE: ALLISON A
RODRIGUEZ, (ORA, NE-FO) | |
ISO
|
TC 198 Sterilization Standards Committee |
|
WG 12 Instructions for reusable device reprocessing |
|
| PRIMARY: CHIU S LIN,
(CDRH, ODE) |
| ALTERNATE: STEVEN E
TURTIL, (CDRH, ODE) | |
ISO
|
TC 198 Sterilization Standards Committee |
|
WG 13 Washer-disinfectors |
|
| ALTERNATE: VICTORIA M
HITCHINS, (CDRH, OSEL) |
| PRIMARY: CHIU S LIN,
(CDRH, ODE) | |
ISO
|
TC 209 Cleanrooms and Associated Controlled Environments
|
|
|
|
| PRIMARY: THOMAS J
ARISTA, (ORA, ORO) |
| ALTERNATE: CHRISTOPHE A
DEMITRUS, (ORA, NE-FO) | |
ISO
|
TC 210 Quality management and corresponding general
aspects for medical devices |
|
|
|
| PRIMARY: CAROL L
HERMAN, (CDRH, OSEL) |
| ALTERNATE: KIMBERLY A
TRAUTMAN, (CDRH, OC) | |
| ISO |
TC 210 Quality management and corresponding general
aspects for medical devices |
|
WG 01 Application of quality systems to medical devices
|
|
| PRIMARY: KIMBERLY A
TRAUTMAN, (CDRH, OC) |
| ALTERNATE: JAN WELCH,
(CDRH, OC) | |
| ISO |
TC 210 Quality management and corresponding general
aspects for medical devices |
|
WG 02 General aspects stemming from the application of
quality principles to medical devices |
|
| PRIMARY: ERIN I KEITH,
(CDRH, OC) | |
ISO
|
TC 210 Quality management and corresponding general
aspects for medical devices |
|
WG 03 Symbols and nomenclature for medical devices |
|
| PRIMARY: CAROL L
HERMAN, (CDRH, OSEL) |
| ALTERNATE: VICTORIA
WAGMAN, (CDRH, OSEL) | |
| ISO |
TC 210 Quality management and corresponding general
aspects for medical devices |
|
WG 04 Application of risk management to medical devices
|
|
| ALTERNATE: ARTHUR A
CIARKOWSKI, (CDRH, ODE) |
| PRIMARY: WILLIAM H
MIDGETTE, (CDRH, OSEL) | |
| ISO |
TC 212 Clinical laboratory testing and in vitro diagnostic
test systems (CLSI) |
|
|
|
| ALTERNATE: SOUSAN S
ALTAIE, (CDRH, OIVD) |
| PRIMARY: STEVEN I
GUTMAN, (CDRH, OIVD) | |
| ISO |
TC 212 Clinical laboratory testing and in vitro diagnostic
test systems (CLSI) |
|
WG 01 Quality and competence in the medical laboratory |
|
| PRIMARY: ELIZABETH A
MANSFIELD, (CDRH, OIVD) |
| ALTERNATE: ARLEEN F
PINKOS, (CDRH, OIVD) | |
| ISO |
TC 212 Clinical laboratory testing and in vitro diagnostic
test systems (CLSI) |
|
WG 02 on Reference systems |
|
| ALTERNATE: SOUSAN S
ALTAIE, (CDRH, OIVD) |
| PRIMARY: MARINA
KONDRATOVICH, (CDRH, OSB) | |
| ISO |
TC 212 Clinical laboratory testing and in vitro diagnostic
test systems (CLSI) |
|
WG 03 General Policy type: In vitro diagnostic products
|
|
| ALTERNATE: SOUSAN S
ALTAIE, (CDRH, OIVD) |
| PRIMARY: STEVEN I
GUTMAN, (CDRH, OIVD) | |
| ISO |
TC 212 Clinical laboratory testing and in vitro diagnostic
test systems (CLSI) |
|
WG 04 on Antimicrobial susceptibility testing |
|
| PRIMARY: FREDDIE M
POOLE, (CDRH, OIVD) | |
ISO
|
TC 229 Nanotechnologies |
|
|
|
|
| ISO |
TC 69 Apllications of statistical methods |
|
|
|
| PRIMARY: RONG TANG,
(CDRH, OSB) | |
| ISO/IEC |
ISO JTC1/SC 07 TAG, Software Engineering |
|
|
|
| PRIMARY: JOHN F MURRAY
JR, (CDRH, OC) |
| ALTERNATE: JOANNA H
WEITERSHAUSEN, (CDRH, ODE) | |
ISO/IEC
|
ISO/IEC JTC Medical Device Software ISO TC 210/IEC 62A |
|
JWG 03 Medical Device Software IEC 62304 |
|
| ALTERNATE: BRIAN J
FITZGERALD, (CDRH, OSEL) |
| PRIMARY: JOHN F MURRAY
JR, (CDRH, OC) | |
ISO/IEC
|
ISO/IEC JWG ISO TC 215/IEC 62A |
|
JWG 07 Risk management for IT-Networks incorporating
medical devices IEC/ISO 80001 |
|
| PRIMARY: BRIAN J
FITZGERALD, (CDRH, OSEL) |
| ALTERNATE: SANDY
WEININGER, (CDRH, OSEL) | |
ISO/IEC
|
ISO/TC 121 & IEC/SC 62D WG |
|
JWG 05: Respiratory gas monitors |
|
| ALTERNATE: MICHAEL J
HUSBAND, (CDRH, ODE) |
| PRIMARY: NEEL J PATEL,
(CDRH, ODE) | |
ISO/IEC
|
ISO/TC 121/SC 01 & SC 03-IEC/SC 62A |
|
Joint Working Group Closed Loop Therapy Delivery Systems
|
|
| TECH EXPERT: MICHAEL J
HUSBAND, (CDRH, ODE) |
| TECH EXPERT: SANDY
WEININGER, (CDRH, OSEL) | |
ISO/IEC
|
ISO/TC 121/SC 03 & IEC/SC 62D |
|
JWG 01: Critical care ventilators |
|
| PRIMARY: MELANIE CHOE,
(CDRH, ODE) |
| ALTERNATE: JENNIFER R
MEDICUS, (CDRH, OC) | |
| ISO/IEC |
ISO/TC 121/SC 03/JWG 02 |
|
TC 121/SC 03/JWG 02 Joint ISO/TC 121/SC 03 - IEC/SC 62A
WG: Alarm systems |
|
| PRIMARY: PETER B
CARSTENSEN, (CDRH, OCER) |
| ALTERNATE: RONALD D
KAYE, (CDRH, OCER) | |
| ISO/IEC |
ISO/TC 121/SC01 & IEC/SC 62D |
|
JWG 01 : Anaesthesia workstations |
|
| PRIMARY: KIMBERLY G
LOVE, (CDRH, ODE) | |
ISO/IEC
|
ISO/TC 121/SC03 & IEC/SC 62D |
|
JWG 04: Pulse oximeters |
|
| ALTERNATE: NEEL J
PATEL, (CDRH, ODE) |
| PRIMARY: SANDY
WEININGER, (CDRH, OSEL) | |
ISO/IEC
|
ISO/TC 121/SC03 & IEC/SC 62D |
|
JWG 08 Clinical Thermometers |
|
| PRIMARY: WILLIAM M
BURDICK, (CDRH, ODE) | |
| ISO/IEC |
ISO/TC 150/SC 06 & IEC/SC 62B |
|
JWG Requirements for the safety and compatibility of
magnetic resonance imaging for patients with an active implantable medical
device |
|
| TECH EXPERT: WOLFGANG
KAINZ, (CDRH, OSEL) |
| ALTERNATE: MITCHELL J
SHEIN, (CDRH, ODE) |
| PRIMARY: TERRY O WOODS,
(CDRH, OSEL) | |
| ISO/IEC |
ISO/TC 150/SC 06 & IEC/SC 62B |
|
JWG Safety requirements for MRI scanning of patients with
an AIMD |
|
|
| ISO/IEC |
ISO/TC 172/SC 07 & IEC/SC 62D |
|
WG 09 Lens removal and vitrectomy devices for ophthalmic
surgery |
|
| PRIMARY: DEXIU SHI,
(CDRH, ODE) | |
| ISO/IEC |
ISO/TC 173 & IEC/SC 62D |
|
JWG 04 Medical Beds |
|
| PRIMARY: JOAN FERLO
TODD, (CDRH, OSB) |
| ALTERNATE: MATTHEW J
POWERS, (CDRH, OC) | |
| ISO/IEC |
JTC 1/SC 22/OWG |
|
Vulnerabilities |
|
| PRIMARY: WILLIAM S
SPEES, (CDRH, OSEL) | |
| ISO/IEC |
TC 121 Anaesthetic and respiratory equipment |
SC 03 Lung ventilators and related equipment |
JWG 07 Non-invasive blood pressure monitoring equipment
|
|
| PRIMARY: CHARLES S HO,
(CDRH, ODE) | |
NEMA
|
Digital Imaging and Communications in Medicine (DICOM)
Standards Committee |
|
|
|
| PRIMARY: KISHALAYA
CHAKRABARTI, (CDRH, OCER) | |
| NEMA |
Digital Imaging and Communications in Medicine (DICOM)
Standards Committee |
|
|
|
| ALTERNATE: KISHALAYA
CHAKRABARTI, (CDRH, OCER) | |
| NEMA |
Digital Imaging and Communications in Medicine (DICOM)
Standards Committee |
|
WG 11 Digital Display |
|
| ALTERNATE: KISHALAYA
CHAKRABARTI, (CDRH, OCER) |
| PRIMARY: ROBERT J
JENNINGS, (CDRH, OSEL) | |
| NEMA |
Digital Imaging and Communications in Medicine (DICOM)
Standards Committee |
|
WG 11 Display Function |
|
| ALTERNATE: KISHALAYA
CHAKRABARTI, (CDRH, OCER) |
| PRIMARY: ROBERT J
JENNINGS, (CDRH, OSEL) | |
NEMA
|
Digital Imaging and Communications in Medicine (DICOM)
Standards Committee |
|
WG 15 Digital Mammography |
|
| PRIMARY: KISHALAYA
CHAKRABARTI, (CDRH, OCER) |
| ALTERNATE: RICHARD V
KACZMAREK, (CDRH, OCER) | |
| NEMA |
Digital Imaging and Communications in Medicine (DICOM)
Standards Committee |
|
WG 16 Magnetic Resonance |
|
| ALTERNATE: WOLFGANG
KAINZ, (CDRH, OSEL) |
| PRIMARY: SUNDER S
RAJAN, (CDRH, ODE) | |
| NEMA |
NEMA/MITA |
Magnetic Resonance |
|
|
| PRIMARY: WOLFGANG
KAINZ, (CDRH, OSEL) |
| ALTERNATE: SUNDER S
RAJAN, (CDRH, ODE) | |
| NEMA |
NEMA/MITA |
Magnetic Resonance Technical Committee |
|
|
| ALTERNATE: WOLFGANG
KAINZ, (CDRH, OSEL) |
| PRIMARY: SUNDER S
RAJAN, (CDRH, ODE) | |
| NFPA |
Committee on Hyperbaric and Hypobaric Facilities |
|
|
|
| PRIMARY: CHRISTY L
FOREMAN, (CDRH, OC) | |
NFPA
|
Laser Fire Protection |
|
|
|
| PRIMARY: DANIEL J
HEWETT, (CDRH, OCER) | |
| RESNA |
Wheelchairs |
|
|
|
| ALTERNATE: MATTHEW R
SCHWERIN, (CDRH, OSEL) |
| PRIMARY: AMY M
SKRZYPCHAK, (CDRH, OC) |
| ALTERNATE: DONALD M WITTERS
JR, (CDRH, OSEL) | |
| UL |
UL 1998 |
Standard for Software in Programmable Components |
|
|
| PRIMARY: PAUL L JONES,
(CDRH, OSEL) | |
| USP |
Official CDRH Correspondent |
|
|
|
|
