A petition is a way for individuals, regulated industry or consumer groups
to petition the agency to issue, change or cancel a regulation, or to take other
action. The agency receives about 200 petitions yearly.
| Docket # |
Petitioner |
Subject |
Date
Filed |
Date of
Interim Response(s) |
Completion
of Petition |
| FDA-1994-P-0023 |
MiniMed Technologies |
Implantable
infusion pump for insulin |
07/15/94 |
03/21/03 |
12/02/04 |
| FDA-2001-P-0128 |
Bio-Rad Laboratories |
Permit
mfrs. to allow the use of symbols in IVD labeling |
07/10/01 |
01/10/02
09/11/02
|
11/18/03 |
| FDA-2001-P-0158 |
Association of Disposable Device Manufacturers |
Regulate
reprocessed single use as reusable medical devices |
08/15/01 |
02/11/02 |
12/29/04 |
| FDA-2001-A-0410 |
PA Department of Health |
Collection
kits marketed by the Osborn Group, Inc. |
08/24/01 |
04/04/02 |
|
| 01P-0389 |
Kyper & Associates LLC |
To
revoke compliance program 7383.003 for class III 510(k) pre-amendment
devices |
09/05/01 |
|
03/13/03 |
| FDA-2002-P-0255 |
St. Jude Medical |
Electronic
labeling programmer/computer that implanted pulse generator |
02/26/02 |
09/11/02 |
09/29/03 |
| FDA-2002-P-0172 |
Nocona General Hospital |
To
amend the MQSA standard and FOI act to allow facilities to respond
and post responses to warning letters on the Internet. |
06/12/02 |
03/27/03 |
10/21/03 |
| FDA-2002-P-0079 |
Russell J. Thomsen, M.D. |
Over-the-counter
sales for hand-held Doppler Fetoscopes |
07/29/02 |
01/24/03 |
06/19/03 |
| 02P-0437 |
Richard Strolworthy |
To
amend the FDA 510(k) policy to include disclosure & labeling requirements |
10/08/02 |
|
04/16/03 |
| FDA-2002-P-0132 |
Zuckerman, Spaeder LLP |
To
post responses to warning letters on the Internet |
10/30/02 |
03/27/03 |
10/21/03 |
| 03P-0105 |
Mettler Electronics Corp. |
FDA
to revoke the medical device tracking order for invusion pumps |
03/14/03 |
|
05/28/03
|
| 03P-0166 |
Associated Pharmacologists & Toxicologists |
Revoke
approval for marketing of menstrual cups |
04/18/03 |
|
11/18/03 |
| FDA-2003-P-0014 |
Tim Milburn, O.D. |
Contact
Lens |
06/24/03 |
|
06/28/04 |
| FDA-2003-P-0403 |
Peter M. Rothenberg, MD, MA |
Exemption
for an accessory to an electrode cable |
06/30/03 |
|
08/14/03 |
| FDA-2003-P-0275 |
Etymotic Research, Inc. |
Over-the-counter
Hearing Aids |
08/11/03 |
|
02/13/04 |
| FDA-2003-P-0342 |
GudHear, Inc. |
Professional
and Patient Labeling for Hearing Aid Devices |
08/11/03 |
|
02/13/04 |
| FDA-2003-P-0184 |
Russel J. Thomsen, M.D. |
Requesting FDA to reconsider decision on Over-the-counter
sales for hand-held doppler fetoscopes |
09/08/03 |
03/08/04 |
06/14/04 |
| FDA-2003-P-0266 |
Endotec, Inc. |
Revoke
the AIP on Endotec |
10/10/03 |
03/26/04 |
|
| FDA-2003-P-0411 |
National Organization for Women. |
Silicone
gel-filled breast implants |
11/03/03 |
|
11/17/03 |
| FDA-2003-P-0124 |
Chemically Associated Neurological Disorders |
Silicone gel-filled breast implants.
http://www.fda.gov/ohrms/dockets/dailys/03/Nov03/
111903/03p-0530-cp00001-vol1.pdf
http://www.fda.gov/ohrms/dockets/dailys/03/Nov03/
111903/03p-0530-cp00001-Exhibit-Tab-A-vol1.pdf
http://www.fda.gov/ohrms/dockets/dailys/03/Nov03/
111903/03p-0530-cp00001-Exhibit-Tab-B-vol1.pdf
http://www.fda.gov/ohrms/dockets/dailys/copyrighted.pdf
http://www.fda.gov/ohrms/dockets/dailys/03/Nov03/
111903/03p-0530-cp00001-Exhibit-Tab-L-vol1.pdf
http://www.fda.gov/ohrms/dockets/dailys/03/Nov03/
111903/03p-0530-cp00001-Exhibit-Tab-M-vol1.pdf
http://www.fda.gov/ohrms/dockets/dailys/copyrighted.pdf
http://www.fda.gov/ohrms/dockets/dailys/03/Nov03/
111903/03p-0530-cp00001-Exhibit-Tab-O-vol1.pdf
http://www.fda.gov/ohrms/dockets/dailys/03/Nov03/
111903/03p-0530-cp00001-Exhibit-Tab-P-vol1.pdf
http://www.fda.gov/ohrms/dockets/dailys/copyrighted.pdf
http://www.fda.gov/ohrms/dockets/dailys/03/Nov03/
111903/03p-0530-cp00001-Exhibit-Tab-T-vol1.pdf
|
11/18/03 |
|
12/04/03 |
| FDA-2003-P-0278 |
Committee for Truth in Psychiatry |
Maintain
ECT in Class III |
12/10/03 |
|
09/03/04 |
| FDA-2004-P-0164 |
Billy Pierson |
Med Watch complaint |
12/22/03 |
|
04/06/04 |
| FDA-2004-P-0407 |
Etymotic Research Inc. |
TV-TIP
Sound Amplifier (WORD) |
01/22/04 |
|
07/20/04 |
| FDA-2004-P-0103 |
BioRad |
Issue
a written opinion stating that unified, truthful labeling for domestic
and international sales is lawful |
02/06/04 |
07/08/04 |
05/02/07 |
| FDA-2004-P-0407 |
Gastroparesis and Dysmotilities Association |
Transfer
Enterra Therapy from HUD to PMA |
02/26/04 |
|
11/04/04 |
| FDA-2004-P-0417 |
Philips Medical Systems |
Exemption
from the medical devices tracking requirements for Heartstream automated
external defibrillators
|
04/6/04 |
|
10/29/04 |
| FDA-2004-P-0349 |
Computerized Thermal Imaging Inc. |
Requesting
FDA to permit CTI to supplement the administrative record in connection
with CTI's PMA approval |
07/1/04 |
09/15/04 |
10/26/04 |
| FDA-2004-P-0223 |
Russel J. Thomsen, M.D. |
Requesting FDA to hold a public hearings to consider
the appropriate regulatory status for low output, hand-held dopppler
fetoscopes.
|
07/26/04 |
|
02/25/05 |
| FDA-2004-P-0028 |
Hyman, Phelps & McNamara, PC |
Requesting
FDA to require manufacturers of reprocessed single-use electrosurgical
cutting and coagulation devices and accessories to submit validation
data.
|
07/28/04 |
|
11/03/05 |
| FDA-2004-P-0100 |
City of Arlington Texas |
Advisory
opinion regarding automatic eternal defibrillators |
08/9/04 |
|
03/15/05 |
| FDA-2004-P-0203 |
Northwest Community Hospital |
FDA
to take action toward medical device manufacturers regarding the interchangeability
of medical devices with one another |
08/18/04 |
|
|
| FDA-2004-P-0285 |
Endotec, Inc |
Request to reclass from III to II the Non-Constrained Mobile Bearing Ankle Prostheses. |
10/13/05 |
04/11/06 |
|
| FDA-2005-A-0248 |
Bill Pierson |
Requesting
the FDA for an opinion regarding hip joint metal constraint
|
02/07/05 |
|
08/02/05 |
| FDA-2005-P-0052 |
RS Medical |
Requesting
that FDA reclassify non-invasive bone growth stimulator from Class
III to Class II
|
02/09/05 |
08/01/05 |
Withdrawn
|
| FDA-2005-P-0382 |
World Wide Medical Technologies |
FDA
safeguard kits for treatment of prostate cancer that use bone wax
|
02/23/05 |
08/16/05 |
07/10/07 |
| FDA-2005-A-0419 |
Jaeckle Fleischmann & Mugel LLP |
Concerns
on 510(k) for a Medical Dental Device
|
04/05/05 |
|
11/08/05 |
| FDA-2005-P-0261 |
International Myopia Prevention Association |
Misbranding
of prescription distance glasses and contact lenses
|
05/02/05 |
10/28/05 |
08/02/06 |
| FDA-2005-P-0067 |
Zuckerman Spaeder LLP |
Requesting disapproval of the silicone-gel filled breast implant products.
|
05/23/05 |
12/05/05 |
11/17/06 |
| FDA-2005-P-0251 |
Life Measurement Operations |
Requesting
a change of classification of Sonamet Body Composition Analyzer
|
05/23/05 |
10/21/05 |
07/02/07 |
| FDA-2005-P-0070 |
Scientific Laboratory Products LTD |
Request
to Change the classification of EEG electrodes from Class II to Class
I
Supplemental information submitted by Petitioner |
05/31/05 |
11/09/05
04/02/06 |
07/02/07 |
| FDA-2005-P-0205 |
Medtronic Xomed |
Request to reclassify Class III to II for the Lamicel
Osmotic Cervical Dilator |
07/26/05 |
|
Withdrawn |
| FDA-2005-P-0136 |
Public Citizen’s Health Research Group |
FDA to establish tighter regulations governing the process by which Medical Devices are reviewed and recalled |
09/14/05 |
05/25/06 |
|
| FDA-2005-P-0063 |
S. Maher |
Reclassification metal/metal hip prostheses from Class III to Class II |
09/19/05 |
03/15/06 |
|
| FDA-2005-P-0262 |
CooperSurgical, Inc. |
Requesting to reclassify the MCCue CUBA Clinical Ultrasonic Bone Sonometry System |
10/26/05 |
|
04/05/06 |
| FDA-2005-P-0324 |
Wright Medical Technology Inc. |
To deny approval of Smith & Nephew premarket approval application for the Birmingham Hip Resurfacing System. |
11/01/05 |
10/31/05 |
05/12/06 |
| FDA-2005-P-0197 |
C. Brown, Consumers for Dental Choice |
Initiate Transfer of Responsibility to Regulate/Classify Dental Amalgam |
11/15/05 |
|
10/26/06 |
| FDA-2005-P-0375 |
C. Brown, Consumers for Dental Choice |
Withdraw Draft Regulation on Mercury Amalgam |
11/16/05 |
|
10/26/06 |
| FDA-2005-P-0008 |
Planmed Oy |
Reclassification of Full Field Digital Mammography from class III to class II |
12/21/05 |
04/18/06 |
|
| FDA-2006-P-0337 |
Alcohol Monitoring System |
Petition for the SCRAM Bracelet |
01/25/06 |
|
|
| FDA-2006-P-0140 |
Regulatory & Clinical Research Institute |
Reclassification of Tissue Adhesive for Soft Tissue |
02/09/06 |
08/23/06 |
05/05/08 |
| FDA-2006-P-0024 |
Chemically Associated Neurological Disorders |
Stay the approvable of any PMA's for silicone gel-filled breast implants |
04/10/06 |
|
11/17/06 |
| FDA-2006-P-0460 |
Banner & Witcoff, LTD |
Initiate Administrative proceedings and enjoining the unlawful sale and distribution by International Tan Markers, Inc. |
04/18/06 |
|
3/14/08 |
| FDA-2006-P-0088 |
Michael Patterson |
Stop LASIK Due to Informed Consent Problems |
05/19/06 |
11/06/06 |
07/20/07 |
| FDA-2006-P-0347 |
Michael Patterson |
Enforce the single-use requirement for all Microkeratomes and their components used by Lasik |
05/19/06 |
11/06/06 |
07/20/07 |
| FDA-2006-P-0287 |
Robert Habig, PhD, Clinical & Laboratory Standards Institute |
Amend practice of assessing the performance of medical device for determining in vitro susceptibility of bacteria or fungi to include CL SI |
06/26/06 |
12/22/06
|
03/05/07 |
| FDA-2006-P-0074 |
American Association of Neurological Surgeons |
Cranial Orthoses exempt from Class II |
07/06/06 |
01/02/07 |
12/26/07 |
| FDA-2006-P-0022 |
Bayer Corporation |
Removal of Labeling for Medisense Precision Advanced Diabetes Management System |
08/08/06 |
|
09/06/06 |
| FDA-2006-P-0336 |
Regeneration Technologies, Inc |
Bone Heterograft Reclassification |
08/17/06 |
10/29/07 |
|
| FDA-2006-P-0021 |
Kerr Corporation |
Urge FDA to take Regulatory Action to Safeguard the Public from Violative Dental Device Distributed by Five Companies,
Including Devices Manufactured in Unregistered Facilities and/or Subject to Tampering |
09/05/06 |
|
01/08/07 |
| FDA-2006-P-0143 |
Public Citizen |
Revoke FDA's Prior Approval of Vagus Nerve Stimulation(VNS) for management of Treatment-resistant Depression
(TRD)
|
09/06/06 |
|
|
| 06P-0375 |
John D. Stephens, M.D. |
Banning of Uro-Gender Test |
09/11/06 |
|
|
| FDA-2006-P-0141 |
John D. Stephens, M.D. |
Banning of Accu-Gender Blood Test |
09/11/06 |
|
|
| FDA-2006-P-0454 |
Jerry Staton |
Order the Church of Scientology to Clearly Disclose the Potential health hazards inherent in the use of the E-Meter and scientology's practice of "auditing."
|
09/19/06 |
03/16/07 |
02/05/08 |
| FDA-2006-P-0149 |
Washington Legal Foundation (WLF)
|
Medical Device Assays Developed by Clinical Laboratories Strictly for In-House (Homebrew) |
10/02/06 |
|
|
| FDA-2007-P-0417 |
Consumer's Union |
Require that all print and electronic advertisements, including Internet advertisements, for implantable devices such as knee, hip, heart valves, cosmetic implants, and other devices |
12/17/07 |
|
|
| FDA-2006-P-0075 |
Michael Patterson |
Stop approving LASIK devices or Ban Lasik Devices
|
12/18/06 |
|
07/20/07 |
| FDA-2006-P-0277 |
Michael Patterson |
Stop all approvals of medical devices used for implantable lens implants |
12/18/06 |
|
07/20/07 |
FDA-2007-P-0116
|
Dean Andrew Kantis |
Take steps to insure the safety of Americans regarding the misuses of Lasik
|
01/05/07 |
|
|
| FDA-2007-A-0279 |
AFrame Digital, Inc. |
AFram MobileCare Monitor system is not a medical device and should not fall under the regulatory authority of the FDA
|
04/24/07 |
|
|
| FDA-2007-P-0005 |
Association of Medical Device Reprocessors |
FDA to Take Action to Subject Certain Cardiac Surgery Devices to 510(k) Requirements |
05/01/07 |
10/29/07 |
|
| FDA–2007–P–0184 |
Judy Slome Cohain |
Restore FDA approval to Tecsana Epi-no birth trainer and to remove the adverse event report on Tecsana Epi-No from FDA website
|
12/12/07 |
|
08/08/08
|
| FDA-2007-P-0120 |
HiFi DNA Tech |
Petitioner request that FDA reclassify the human papillomavirus (HPV) DNA nested Polymerase chain reaction (PCR) detection device from class III to class II (513(f))
|
05/22/07 |
|
|
| FDA-2007-P-0288 |
Clinical & Laboratory Standards Institute (CLSI) |
Clear new susceptibility test devices or modification of existing devices using Clinical and Laboratory Standards Institute (CLSI) interpretive breakpoints in those instances regarding susceptibility
|
06/08/07 |
12/06/07 |
|
| FDA-2007-P-0115 |
Clinical & Laboratory Standards Institute (CLSI) |
Request that CDRH allow 510(k) clearance of devices for antimicrobial susceptibility testing of Streptococcus pneumoniae with penicillin
|
06/29/07 |
12/06/07 |
|
| FDA-2007-P-0117 |
Health Care Without Harm |
Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
|
08/14/07 |
|
|
| FDA-2007-A-0163 |
Alston & Bird LLP |
Advisory Opinion request for Mandatory Black Box warnings on all Bovine Thrombin Products
|
08/24/07 |
02/20/08 |
06/02/08 |
FDA-2007-P-0118
FDA-2008-P-0066 |
Thomas J. Quinn |
Strict and immediate enforcement of performance standards contained in: 21 CFR 10.20(g)(h) and 1020.33(c); 21 CFR 1040.10(h); 21 CFR 820.170
|
08/27/07 |
|
|
| FDA-2007-P-0464 |
Ralph D. Childs |
Electronic Product Radiation Control
|
10/03/07 |
|
|
| FDA-2008-P-0196 |
Carmel Pharma |
Withdraw Teva 510(k)s |
03/25/08 |
|
|
| FDA-2008-P-0197 |
W.J. Kennick |
Tomatis Electronic Ear |
03/20/08 |
09/12/08 |
|
| 08P-0252 |
Richard W. Treharne, PhD |
Withdraw FDA Policy on Establishing Preamendments Status |
04/21/08 |
|
|
| FDA-2008-P-0282 |
Pneumex, Inc. |
Request that FDA reclassify Pneumex's device known as the Pneu-Vibe-Trac device from 510(k) requirements |
04/17/08 |
|
06/18/08 |
| FDA-2008-P-0159 |
Missouri State Board of Examiners for Hearing Instrument Specialists |
Application for Exemption from Preemption of Device Requirements
|
03/05/08 |
|
|
| FDA-2008-P-0353 |
Fuerst, Humphrey, Ittleman, PL |
Petition for Stay of Action under 21 CFR 10.35 (concerning HairMax LaserComb medical devices) |
06/18/08 |
|
10/03/08 |
FDA-2008-P-0388
|
Links Medical Products, Inc. |
Petition for Reclasssification Under 513(f) - Reclassify the Tablet Crusher and Pouch and collectively the Tablet Crushing System currently regulated under 21 CFR Part 880.6430, from Class I to Class II.
|
07/09/08
|
|
|
| FDA-2008-P-0531 |
University of Virginia Health System |
Petition to Ban Cornstarch Powder on Medical Gloves
|
09/26/08 |
|
|
