| 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 |
|
| FDA-2001-P-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 |
| FDA-2002-P-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 |
| FDA-2003-P-0105 |
Mettler Electronics Corp. |
FDA to revoke the medical device tracking order for invusion pumps |
03/14/03 |
|
05/28/03 |
| FDA-2003-P-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 |
|
12/03/03 |
| FDA-2003-P-0124 |
Chemically Associated Neurological Disorders |
Silicone gel-filled breast implants.
|
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 |
04/06/04 |
|
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 |
07/01/04 |
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 |
08/09/04 |
|
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 |
05/22/09 |
| 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 |
|
|
| 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 |
11/10/05 |
05/25/06 |
07/11/11 |
| 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 |
|
|
| FDA-2006-P-0141 |
John D. Stephens, M.D. |
Banning of Accu-Gender Blood Test |
09/11/06 |
|
10/12/06 |
| FDA-2006-P-0149 |
Washington Legal Foundation (WLF) |
Medical Device Assays Developed by Clinical Laboratories Strictly for In-House (Homebrew) |
10/02/06 |
|
07/31/14 |
| 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-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-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 |
|
09/08/09 |
| FDA-2007-P-0464 |
Ralph D. Childs |
Electronic Product Radiation Control |
10/03/07 |
|
09/08/09 |
| 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-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 |
|
03/30/10 |
| FDA-2008-P-0196 |
Carmel Pharma |
Withdraw Teva 510(k)s |
03/25/08 |
08/20/08 |
04/04/11 |
| FDA-2008-P-0197 |
W.J. Kennick |
Tomatis Electronic Ear |
03/20/08 |
09/12/08 |
11/26/08 |
| FDA-2008-P-0252 |
Richard W. Treharne, PhD |
Withdraw FDA Policy on Establishing Preamendments Status |
04/21/08 |
|
12/21/10 |
| 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-N-0163/PRC |
Moms Against Mercury, et al. |
Reconsider the Classification of Dental Amalgam as Class II |
09/03/09 |
|
01/27/15 |
| FDA-2008-N-0163/PRC |
Citizens for Health, et al. |
Reconsider the Classification of Dental Amalgam as Class II |
09/03/09 |
|
01/27/15 |
| FDA-2008-P-0319 |
Lauranell H. Burch |
Ban the use of all Refractive Surgery Lasers for LASIK Surgery and Acknowledge and Enforce Remedy for the Misbranding of lasers used for LASIK |
05/28/08 |
|
07/16/09 |
| 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-0444 |
Codonics, Inc. |
FDA conduct an immediate inspection of the Datcard Systems, Inc. facilities, and that the PacsCube products, manufactured by DatCard Systems, Inc. be detained for a determination of seizure, injunction, and/or other appropriate relief |
08/06/08 |
|
04/19/11 |
| FDA-2008-P-0531 |
University of Virginia Health System |
Petition to Ban Cornstarch Powder on Medical Gloves |
10/02/08 |
03/09/09 |
|
| FDA-2008-P-0533 |
Fuerst, Humphrey, Ittleman, PL |
Take Action to Address the Growth of Online/Internet Advertising of Drugs and Devices |
09/26/08 |
|
|
| FDA-2008-P-0585 |
Elliot Farber |
Artificial Eyes Lubricant |
11/04/08 |
|
|
| FDA-2008-P-0630 |
The Prescription Project |
Take Action to Address the Growth of Online/Internet Advertising of Drugs and Devices |
12/08/08 |
05/31/09 |
|
| FDA-2008-A-0619 |
Jeffrey K. Shapiro |
Request for Section 9 Limitations on 510(k) Exemption Advisory Opinion |
12/1/09 |
07/06/09 |
03/15/11 |
| FDA-2008-P-0638 |
Genetech, Inc. |
Require that all in vitro diagnostic tests intended for use in drug or biologic therapeutic decision making be held to the same scientific and regulatory standards |
12/09/08 |
|
07/31/14 |
| FDA-2009-P-0023 |
Electro Medical Systems Corp. |
Request that FDA (i) revoke 510(k) Number K072809 from FDA's Premarket Notification Database and (ii) recall the D-Actor Vibration Massage System from the U.S. Marketplace |
01/14/09 |
|
|
| FDA-2009-P-0094 |
American Association for Health Freedom |
Consider the Potential Risks of Exposure to Bisphenol-A for Dental Applications |
02/18/09 |
08/10/09 |
|
| FDA-2009-P-0105 |
Williams Kherkher Hart Boundas, LLP |
Petition for FDA (1) inspection of all facilities where Medtronic sprint fidelis leads were manufactured and (2) the withdrawal of PMAs for the Medtronic sprint fidelis leads retroactive to September 2004 |
02/18/09 |
|
05/18/10 |
| FDA-2009-P-0117 |
Kimberly-Clark Health Care |
Petition to ban Cornstarch Powder on Medical Gloves |
02/26/09 |
|
|
| FDA-2009-P-0150 |
Arthur K. Yellin |
Create a Separate Classification for Gloves used in Preparing and Administering Chemotherapeutic Drugs |
03/18/09 |
|
08/24/10 |
| FDA-2009-P-0207 |
Thomas Quinn |
Request for Immediate Class One Recall of Philips Medical Devices |
05/05/09 |
11/27/09 |
09/27/13 |
| FDA-2009-P-0253 |
Scott A. Tolchin |
Petition for FDA to Inspect LASIK Cinics to Ensure Compliance with 21 CFR 803, Subpart C User Facility Reporting Requirements |
05/25/09 |
|
05/18/10 |
| FDA-2009-P-0282 |
Pepper Hamilton, LLP |
Petition for FDA to Detain devices within the "Remote Medication Management Systems" device type |
06/19/09 |
|
12/10/09 |
| FDA-2009-P-0305 |
Hygeia II Medical Group, Inc. |
Petition Seeking Clarification and Review of Labeling for Breastpumps and Mother/Baby Products in Contact with Human Breastmilk |
07/01/09 |
|
|
| FDA-2009-P-0357 |
International Academy of Oral Medicine and Toxicology |
Petition to Ban Dental Amalgam or Classify the Device as Class III |
07/28/09 |
|
01/27/15 |
| FDA-2009-P-0362 |
Ryszard Rokicki |
Request that FDA Issue an Order Mandating Inspection of every peripheral stent, cardiovascular stent, heart valve and IVC filter composed of Nitinol for Intermetallic Inclusions before Sterilization |
07/29/09 |
|
02/25/11 |
| FDA-2009-P-0437 |
Edward Manougian |
Testing Methods for products to be used by the lay public in emergency situations |
03/7/2010 |
|
08/24/10 |
| FDA-2009-P-0593 |
Grove Medical LLC |
Request for an Extension of Time for Packaging Compliance under Special Controls Regulation 21 CFR 884.5300 and Request that FDA Stay Enforcement of Labeling Requirements to Allow Grove Medical LLC to Complete the Use of its Packaging Material |
12/15/09 |
|
04/10/10 |
| FDA-2009-P-0596 |
VQ OrthoCare Patient-Centered Solutions |
Reverse the 510(k) Approval for J-Stim 1000 |
12/16/09 |
|
|
| FDA-2010-P-0045 |
Richard Edlich |
Remove the consumer report "Medical Glove Powder Report from the FDA website. |
01/19/10 |
|
|
| FDA-2010-P-0052 |
Dr. Richard Edlich |
Remove Cornstarch Powder from Medical Gloves Because It Promotes the Growth of Cancer |
01/20/10 |
|
|
| FDA-2010-P-0056 |
Richard Edlich |
Prepare Informed Consent Brochures that Dentists must give to their Patients who Receive Dental Restorations |
01/20/10 |
|
|
| FDA-2010-A-0154 |
R. Sheridan Consulting, LLC |
Request for an Advisory Opinion Concerning the Protection of Human Subjects |
03/11/10 |
|
|
| FDA-2010-N-0268 |
Consumers for Dental Choice |
Dental Products Panel Meeting |
10/04/10 |
|
04/18/11 |
| FDA-2010-P-0339 |
Richard Edlich |
Require the Use of Powder Free Double Glove Hole Indicator System |
06/23/10 |
|
01/31/12 |
| FDA-2010-P-0352 |
Richard Edlich |
Revise Classification of Powdered Exam and Surgical Gloves |
06/30/10 |
|
|
| FDA-2010-P-0359 |
Mark Heller/ Goodwin Procter LLP |
Petition Requesting the Reclassification of Hemostatic Devices |
07/02/10 |
12/10/10 |
|
| FDA-2010-P-0392 |
Richard Edlich |
Request to Make Final Decision on Petition to Ban Glove Powder |
07/15/10 |
|
|
| FDA-2010-P-0397 |
Richard Edlich |
Ban the Use of Cornstarch Powder in Surgical Gloves in In Vitro Fertilization Labs |
07/22/10 |
|
|
| FDA-2010-P-0401 |
Steve Gupta, M.D. |
Revoke Alair PMA Approval |
07/27/10 |
01/18/11 |
12/2/11 |
| FDA-2010-P-0446 |
Richard Edlich |
Require Warning Label that Glove Hole Leakage rate is 1.5% on each surgical glove and packaging |
08/20/10 |
|
1/31/12 |
| FDA-2010-P-0489 |
Dr. Richard Edlich |
Establish Guidelines for Responding to a Citizen Petition |
09/14/10 |
|
|
| FDA-2010-P-0520 |
Extremity Innovations, Inc |
Reclassification Petition for Injectable Silicone |
02/22/10 |
03/09/11 |
12/15/11 |
| FDA-2010-P-0559 |
Ben Z. Beiski |
GenNarino Transcutaneous Electrical Nerve Stimulation Intraoral Device for Xerostomia Relief
|
12/10/10 |
|
|
| FDA-2010-P-0580 |
Ralph McBride |
Clarify Approval of Medronic Insulin Pump (P980022/S13) |
11/10/10 |
04/14/11 |
|
| FDA-2010-P-0592 |
Dr. Richard Edlich |
Ban Sale of Liquid Mercury |
11/17/10 |
06/02/11 |
08/12/11 |
| FDA-2010-P-0610 |
Dr. Richard Edlich |
Revise Classification of Dental Restorative Materials & Liquid Mercury |
11/23/10 |
|
|
| FDA-2010-P-0617 |
Dr. Richard Edlich |
Ban Dental Amalgam (Severe Diseases) |
11/24/10 |
|
|
| FDA-2010-P-0619 |
Dr. Richard Edlich |
Ban Dental Amalgam (Effects on Pregnant Women/Fetus) |
11/29/10 |
|
|
| FDA-2011-P-0022 |
Waxler Regulatory Consultancy LLC |
LASIK |
01/07/11 |
07/07/11 |
06/23/14 |
| FDA-2011-P-0022/PRC |
Waxler Regulatory Consultancy LLC |
Request that FDA Withdraw Premarket Approvals for all LASIK Excimer Laser Devices & Issue a Voluntary Recall of These Devices - Reconsideration Petition |
9/2/2014 |
1/23/2015 |
|
| FDA-2011-P-0032 |
Anika Therapeutics |
Reconsideration of Denial of Approval of Pre-Market Application P090031 via Independent Advisory Committee Review |
01/11/11 |
|
03/24/11 |
| FDA-2011-P-0083 |
Pharmacists Planning Service, Inc. (PPS) |
Remove Nonoxynol-9 (N-9) in Condoms from USA Distribution |
02/09/11 |
|
|
| FDA-2011-P-0150 |
Mike Sammon, SureTek Medical |
Enforcement of Premarket Notification Requirements Regarding Single-Use Devices |
03/08/11 |
08/08/11 |
|
| FDA-2011-P-0151 |
Brian C. Mandingo |
Requesting Enforcement Against Church of Scientology for E-Meter |
03/08/11 |
|
|
| FDA-2011-P-0290 |
Northeast Scientific/Mitchell Fuerst, Esq. |
Agency Decision on Premarket Notification 510 (k) K090661 |
04/20/11 |
|
08/15/11 |
| FDA-2011-P-0331 |
Michael A. Carome, M.D., Public Citizen Health Research Group |
Request to Ban Cornstarch Powder on Medical Gloves & Ban Use of All Natural Latex Rubber Medical Gloves |
05/02/11 |
10/20/11 |
|
| FDA-2011-P-0355 |
Joseph V. Gulfo, M.D., MELA Sciences |
Request to Enforce 10/20/2004 Sec. 520(g)(7) Protocol Agreement |
05/09/11 |
|
|
| FDA-2011-P-0374 |
Lanny J. Davis & Assoc., Robert R. Hopper & Assoc. |
Request Investigation of 3M Corporation and Its Conduct in Baclite Clinical Trial "A Covered Clinical Study" |
05/11/11 |
|
|
| FDA-2011-P-0438 |
Public Citizen Health Research Group |
Request to Ban the Marketing of, and to Recall Beside Assistant Bed Handles Manufactured by Bed Handles Inc. Models BA10W and BA10W-6 |
05/31/11 |
11/03/11 |
12/19/13 |
| FDA-2011-P-0474 |
Mark E. DuVal and Mark E. Garner, DuVal & Assoc. |
Request Stay of Agency Action That Would Result in 510(k) Clearance of Smith & Nephew PICO Single Use Portable Negative |
06/13/11 |
12/05/11 |
|
| FDA-2011-P-0475 |
Dr. S. Albert Edwards |
Investigate Edwards Lifesciences, Northwestern University IRB and Dr. Patrick McCarthy and Annuloplasty Rings |
06/14/11 |
12/02/11 |
02/27/12 |
| FDA-2011-P-0479 |
Dr. S. Albert Edwards |
Request to Investigate Placement of Annuloplasty Rings & Number of Deaths from Annuloplasty Rings for Past 5 Years |
06/14/11 |
12/02/11 |
|
| FDA-2011-P-0497 |
Daniel J. Popeo, Washington Legal Foundation |
Request Use of Advice from IOM Committee That Fails to Comply with FACA's Fair Balance Requirement |
06/13/11 |
|
02/12/12 |
| FDA-2011-P-0552 |
Robert Wagner |
Request to Issue Regulations Related to Outdoor Luminaires |
07/19/11 |
|
12/16/11 |
| FDA-2011-A-0562 |
Russell Statman, Esq., Registrar Corp. |
Responsibility of U.S. Importers and Foreign Manufacturers of Radiation Emitting Devices Where a Device is
Manufactured or Assembled Outside the United States |
07/25/11 |
|
|
| FDA-2011-P-0590 |
Kim Witczak and William K. Vaughan |
Request Administrative Action to Improve Involvement of Patients & Consumers in Reporting of Adverse Drug and Device Events |
08/10/11 |
|
|
| FDA-2011-P-0641 |
Michael Carome, Public Citizen's Health Research Group |
Request to Ban Marketing of Non-Absorbable Surgical Mesh Products Designed and Labeled for Transvaginal Repair of Pelvic Organ Prolapse |
08/26/11 |
02/10/12 |
|
| FDA-2011-P-0660 |
Robert J. Michalik, Esq. RAC, RegulatoryPro.com |
Request to Amend Regulation Regarding Absorbable Hemostatic Devices (21 CFR 878.4490) |
09/09/11 |
02/07/12 |
|
| FDA-2011-P-0777 |
Thomas W. Nerney, Institute for Health Quality and Ethics |
Request to Fully Implement and Enforce Mammogram Quality Standards Amendment Act of 1992 |
10/21/11 |
04/12/12 |
10/28/13 |
| FDA-2011-P-0804 |
Richard Keller, Bruno Independent Living Aids, Inc. |
Exempt Stairlifts (Stairway Chairlifts) from Premarket Notification Requirements |
11/07/11 |
|
02/04/13 |
| FDA-2011-P-0820 |
G. Scott Crowther, PE |
Reconsider Dose of Mercury Released From Dental Amalgam & Ban Dental Amalgam and Its Components |
11/09/11 |
|
|
| FDA-2011-P-0851 |
Sharon Starowicz, Orthopedic Manufacturers Assoc. |
Reclassification to FDA RE: 513(e) Posterior Cervical Pedical and Lateral Mass Screws |
11/23/11 |
|
|
| FDA-2011-P-0882 |
Richard Keller, Bruno Independent Living Aids, Inc. |
Request to Exempt Inclined Platform Lifts and Vertical Platform Lifts, Class II Devices, From Premarket Notification Requirement of Section 510(k) of The Act |
12/02/11 |
05/03/12 |
03/04/13 |
| FDA-2011-P-0923 |
Michael A. Carome, M.D., Public Citizen's Health Research Group |
Request to Immediately Withdraw Approval of Humanitarian Device Exemption (HDE) Application for Wingspan Stent System
|
12/22/11 |
05/18/12 |
08/08/12 |
| FDA-2012-P-0040 |
Fischer Surgical |
Requested Review of NSE Response to 510(k) Submission K110734 |
01/10/12 |
|
02/23/12 |
| FDA-2012-P-0137 |
Robert L. Sheridan, R. Sheridan Consulting, LLC |
Request to Take Appropriate Actions to Ensure that CDRH Correctly Interprets Provisions of Sections 513(i) and 520(g) of FDCA and Related Regulations and Guidance Documents |
02/09/12 |
|
|
| FDA-2012-P-0153 |
Intertek |
Request to Refrain From Taking Admin Action Against Intertek by Dismissing Them as Accredited Person for 510(k) Review Under FDAMA of 1997 Without Due Process |
02/13/12 |
08/09/12 |
|
| FDA-2012-P-0260 |
Fisher Wallace Laboratories |
Request that Commissioner Investigate Actions Taken by CDRH Related to 8/8/2011 RE: Cranial Electrotherapy Stimulator (CES) Devices |
03/09/12 |
|
|
| FDA-2012-P-0270 |
Lawrence Paros, Neuro Fitness LLC |
Request Commissioner to Take Certain Actions AS They Pertain to the Neurological Review Panel of 2/10/2012 in Consideration of Requests for Reclassification for the Cranial Electrotherapy Stimulator (CES) |
03/15/12 |
|
|
| FDA-2012-N-0378 |
BioElectronics Corporation |
Effective Date of Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses |
07/23/12 |
|
|
| FDA-2012-P-0493 |
Leroy Leslie Hamilton, Ph.D. |
Request to Reclassify Cranial ElectrotherapyStimulator from Class III to Class II |
05/16/12 |
|
|
| FDA-2012-P-0747 |
Leroy Leslie Hamilton |
Request Commissioned to Conduct Impartial Investigation Regarding From FDA 3429 General Device Classification Questionnaire |
07/10/12 |
|
03/04/13 |
| FDA-2012-P-0963 |
Charles J. Zimmerer |
Action Regarding Manufacturing and Use of Blood Nutrition Software |
09/04/12 |
03/19/13 |
|
| FDA-2012-P-1026 |
Christine Humphrey on behalf of Synergy Health Concepts |
Stay the Effective Date of Any Possible Disclosure Concerning the Issuance of 9/5/2012 Warning Letters |
09/25/12 |
|
12/03/13 |
| FDA-2012-P-1107 |
Hogal Lovells for FzioMed |
Petition for Reconsideration--Denial of FzioMed, Inc.'s Premarket Approval Application for Oxiplex Gel |
11/05/12 |
|
03/19/15 |
| FDA-2012-P-1155 |
DEKA Research & Dev. Corp. |
Petition for Reclassification of Stair-Climbing Wheelchairs to Class II |
11/20/12 |
|
01/27/14 |
| FDA-2013-P-0048 |
James Reichmann |
Reclassify Drug Ondansetron (Zofran) |
01/07/13 |
07/03/13 |
|
| FDA-2013-P-0070 |
Ikaria, Inc. |
Rescind 510(k) Clearance for GeNo, LLC |
01/14/13 |
07/10/13 |
|
| FDA-2013-P-0076 |
DuVal & Associates; Minnesota Medical Device Alliance |
Stay of Action in Process of Reviewing 510(k)'s |
01/16/13 |
07/03/13 |
07/25/14 |
| FDA-2013-P-0199 |
Richard Karcich |
Citizen Petition Request to FDA to Issue New Regs or Amend Existing Regs Covering Measurement of Safety and Reliability of Software in Medical Devices |
02/15/13 |
|
|
| FDA-2013-P-0235 |
Wess Eric Sharpe |
Request FDA to Reconsider Its Classification of Lantos 3D Ear Scanner 874.1090 Auditory Impedence Tester Because Devices Should Be Classified as Class II, Not Class I |
02/26/13 |
|
|
| FDA-2013-P-0667 |
American Clinical Lab Association |
Regulating Laboratory Developed Tests (LDTs) |
06/04/13 |
11/26/13 |
07/31/14 |
| FDA-2013-P-0735 |
Mario Morais |
Support Chronic Cerebrospinal Venous Insufficiency (CCSVI) as an MS Treatment |
06/11/13 |
|
|
| FDA-2013-P-0944 |
Jeffrey G. Thomas on behalf of Marteen Moore |
515(g) Petition Regarding the Conditions of Premarket Approval of the DURASEAL® Spinal Sealant |
08/01/13 |
|
|
| FDA-2013-P-0949 |
Garrett Skelly, Esq. |
Amend External Prosthetic Order and Procedures and Classification of All External Prosthetic Devices in 21 CFR 890.3420 and 21 CFR 890.3500 to Read as Both "Prescription" and "OTC" in Particular C-Leg K991590 |
08/09/13 |
02/05/14 |
03/21/14 |
| Reconsideration - Amend External Prosthetic Order and Procedures and Classification of All External Prosthetic Devices in 21 CFR 890.3420 and 21 CFR 890.3500 to Read as Both "Prescription" and "OTC" in Particular C-Leg K991590 |
04/08/14 |
|
|
| FDA-2013-P-0997 |
Thomas J. Quinn |
Requesting FDA to Amend 21 CFR Section 1030, Microwave and Radio Frequency Emitting Products, to Include Nuclear Magnetic Resonance Imaging, Product Code LNH and LNI |
08/13/13 |
|
|
| FDA-2013-P-1080 |
Garrett Skelly, Esq., for Reginald Burgess |
Requesting FDA to amend 21 CFR 820.198 to add a provision regarding Manufacturer Complaint Files |
09/04/13 |
02/24/14 |
06/02/14 |
| FDA-2013-P-1297 |
Kevin Boulton |
Issue a Declaratory Order Finding That the Petitioner has Standing and That Harmony Cone Ear Candles (HCEC) are not "Devices" Under FDCA 201 (h) |
10/25/13 |
|
|
| FDA-2013-P-1374 |
Frederick S. Mayer, R.Ph., M.P., Pharmacists Planning Service, Inc. |
Issue a Federal Regulation to Augment FDA Citizen's Petition For Public Hearings to Establish Standards on Cellphone Radiation Adverse Health Effects |
11/20/13 |
03/07/14 |
|
| FDA-2013-P-1611 |
Clarissa Clarke |
Amend Two Regulations Within The Code of Federal Regulations, Title 21--Food and Drugs, Chapter 1, Subpart H--Medical Devices, Part 872--Dental Devices |
12/12/13 |
|
|
| FDA-2014-P-0038 |
Jennifer Butsch, Riverain Technologies |
Request to Reclassify ClearRead+Detect, a CADe device, from Class III to Class II |
12/18/13 |
06/17/14 |
|
| FDA-2014-P-0111 |
Ms. Xiang Zhang, LaMaitre Vascular, Inc. |
Section 513(e) Reclassification Petition for Animal Tissue Graft of 6rnrn and Greater (LXA) Devices from Class III to Class II |
01/23/14 |
07/07/14 |
|
| FDA-2014-P-0143 |
Gail Gudmundsen |
Personal Sound Amplification Products |
01/28/14 |
07/14/14 |
|
| FDA-2014-P-0158 |
H.Christopher Schweitzer, Ph.D., F-AAA |
Refrain From Taking any Form of Additional Administrative Action That Affects the Specific Type of Consumer Product That CDRH Refers to as Personal Sound Amplification Products |
01/30/14 |
07/22/14 |
|
| FDA-2014-P-0159 |
Mead C. Killion, Ph.D., Sc.d. (Hon) |
Announce FDAs Intent to Immediately Exercise Enforcement Discretion in Regard to Any and All Violations of the Current Regulations Governing the Labeling and Conditions for Sale of Hearing Aids |
01/30/14 |
07/22/14 |
|
| FDA-2014-P-0231 |
Adaptive Engineering Inc. |
Exempt the Manually Operated Wheelchair Lift From the 510(K) Premarket Notification |
02/24/14 |
|
|
| FDA-2014-P-0283 |
Leroy L. Hamilton |
Revise Form FDA 3429 to Indicate the Appropriate Classificationof a Medical Device |
03/06/14 |
|
05/16/14 |
| FDA-2014-P-0290 |
Leroy L. Hamilton |
Direct CDRH to Include Product Codes Where Appropriate in Notices & Other Information Published for Specific Categories of Medical Devices |
03/10/14 |
|
05/16/14 |
| FDA-2014-P-0427 |
Medicem Technology |
Reclassify Dilapan |
04/10/14 |
|
08/14/14 |
| FDA-2014-P-0445 |
Robert Larry Lytle |
Requests that FDA recognize that the private member associations created by Petitioner deal only with PMA members (not with the public), that the lawful acts of the PMAs are generally immune from or beyond the scope and purview of FDA's laws and regulations. |
04/14/14 |
05/30/14 |
11/15/16 |
| FDA-2014-P-0654 |
Edwards Life-Sciences |
FDA grant a variance from specific quality system requirements for the delivery systems and accessories of the SAPIEN XT THV |
05/20/14 |
|
|
| FDA-2014-P-0724 |
Barbara Spohn-Lillo, Rocky Mountain Anaplastology Inc. |
FDA to Consider Barbara Spohn-Lillo as a Clinical Practitioner and Exempt Rocky Mountain Anaplastology, Inc. from Device Registration and Listing |
11/03/14 |
04/30/15 |
08/30/16 |
| FDA-2014-P-0802 |
Moon T. Kwon |
FDA withdraw its draft guidance and refrain from taking any action affecting personal sound amplification products and cease further efforts to expand the scope of the generic device known as a hearing aid |
06/17/14 |
07/22/14 |
|
| FDA-2014-P-0825 |
OrthoFix |
Requesting that the FDA not enforce 801.30(a)(1) for implants in the control of third parties provided labeling activities took place prior to the regulation implementation deadline identified by the FDA device class. Also requests that FDA refrain from requiring relabeling for product labeled prior to regulation implementation deadline and its 3 year implementation period |
06/19/14 |
12/17/14 |
|
| FDA-2014-P-0831 |
OrthoFix |
FDA not enforce 801.30(a)(1) for instruments in the control of third parties, provided labeling activities took place prior to the regulation implementation deadline identified by the FDA by device class |
06/20/14 |
12/17/14 |
|
| FDA-2014-P-0687 |
Margaret Moline |
Requesting FDA to revoke import alerts EPFX device |
10/31/14 |
04/22/14 |
08/17/16 |
| FDA-2014-P-0919 |
Shumaier |
FDA withdraw its draft guidance regarding Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products and refrain from taking further action that directly or indirectly restricts availability of hearing assistive devices and personal sound amplification products |
07/01/14 |
12/23/14 |
|
| FDA-2014-V-1503 |
Timothy J. Connors, Integra LifeSciences Corporation |
Approve a variance request that considers the device as a compliant system consisting of the electrode connected to the Integra EEG cable (as opposed to considering only the electrode) |
10/02/14 |
03/30/15 |
05/22/15 |
| FDA-2014-P-1673 |
Tia Gonnella |
Request that the Commissioner of Food and Drugs amend the current content and format of High Level Disinfectant characterization for use with semi critical items employed in the healthcare setting |
10/23/14 |
12/22/14 |
|
| FDA-2015-P-0014 |
Edward L. Boshnick, O.D.; Roger D. Davis, Ph.D.; Richard B. Smith, Ph.D. |
Request that the FDA add a black box warning concerning the high incidence of induced visual symptoms to the device labeling of all excimer lasers used in laser eye surgery presently on the market in the U.S. |
01/05/15 |
|
|
| FDA-2015-P-0051 |
Christopher E. Bossi, Inrange Systems, Inc. |
Take action to protect patient safety by detaining the product manufactured or sold by; PharmRight Corporation under the product name "Livi" |
01/06/15 |
|
03/02/15 |
| FDA-2015-P-0095 |
Mark DuVal, DuVal and Assoc. (Leonhard Lang, GmbH) |
Request that the FDA grant an exemption from the medical device tracking requirements recently ordered |
01/09/15 |
|
|
| FDA-2015-P-0569 |
Marcus J. Susen & Justin Parafinczuk, Koch Parafinczuk & Wolf, P.A. |
Request that FDA take various actions against Bayer Healthcare Pharmaceuticals, Inc., and its subsidiaries regarding the “Essure” product |
01/24/15 |
|
03/26/15 |
| FDA-2015-P-0703 |
Sarah Salem-Robinson |
Issue Ban on Laparascopic Power Morcellators |
03/05/15 |
|
|
| FDA-2015-P-1197 |
Brian Orwat, Stryker Medical |
Request amendment to Regulation 21 CFR 890.3110 Electric Positioning Chair to Exempt Classification from Premarket Notification |
04/13/15 |
|
|
| FDA-2015-P-1674 |
Kelly Quick, Globus Medical, Inc |
FDA not enforce 801.30(a)(1) for implants that were commercially distributed and held for sale to potential purchasers prior to the regulation implementation deadline identified by the FDA by device class |
05/12/15 |
|
|
| FDA-2015-P-1924 |
Hunton and Williams LLP |
Requesting FDA issue an order declaring Zeltiq CoolSculpting System to be NSE |
05/29/15 |
10/08/15 |
03/14/16 |
| FDA-2015-P-2375 |
Public Citizen Health Research Group |
Requests that FDA withdraw approval of Seprafilm Bioresorbable Membrane, premarket approval application number P950034, and initiate a mandatory recall of this product |
07/07/15 |
10/02/15 |
|
| FDA-2015-P-2481 |
SweetSpot Diabetes Care, Inc. |
requesting reclassification of diabetes data management software devices from class II to class I |
07/15/15 |
|
|
| FDA-2015-P-2820 |
Alston and Bird (the Center for Responsible Science) |
Requests FDA modify existing regulations that govern requirements for INDs, IDEs, and NDAs |
08/03/15 |
03/11/16 |
|
| FDA-2015-P-2854 |
Olsson Frank Weeda Terman Matz on behalf of Provensis Ltd. |
Requests FDA withdraw approval of Premarket Approval Number P140018 for the VenaSeal® Closure System |
08/05/15 |
|
|
| FDA-2015-P-3107 |
DuVal & Associates on behalf of Ferrosan Medical Devices A/S |
Requests FDA refrain from taking further action to reclassify collagen-based absorbable hemostatic devices |
08/25/15 |
01/21/16 |
|
| FDA-2015-P-3108 |
DuVal & Associates on behalf of Ferrosan Medical Devices A/S |
Requests FDA refrain from taking further action to reclassify collagen-based absorbable hemostatic devices |
08/25/15 |
|
|
| FDA-2015-M-1065 |
Reed Smith LLP |
Reconsideration of PMA Approval of AutoSPray Dural Sealant |
09/14/15 |
10/16/15 |
|
| FDA-2015-P-3364 |
Leroy L. Hamilton, Ph.D. |
Request FDA to Complete and return "return receipt" postcards when they receive Certified or Registered letters with the green return receipt postcards attached |
09/08/15 |
06/21/16 |
|
| FDA-2015-P-3365 |
Inrange Systems, Inc. |
Requests FDA to detain Life Integrating Technologies product Lumma |
09/14/15 |
12/16/15 |
|
| FDA-2015-P-3778 |
Orthofix, Inc. |
Requests FDA to enact the proposed rule dated 4/19/2013 to facilitate implementation of the Universal Device Identification Regulation |
10/16/15 |
04/11/16 |
08/02/16 |
| FDA-2015-P-3876 |
World Alliance for Mercury-Free Dentistry |
Requests FDA to make the changes included in this Citizen Petition to FDA's mercury amalgam rule so that the rule will conform with the Minamata Convention on Mercury |
10/20/15 |
04/19/16 |
|
| FDA-2015-P-4945 |
Ryszard Rokicki |
Request FDA to order Bayer to use petitioners patented methodology on Essure |
12/21/15 |
03/14/16 |
|
| FDA-2016-P-1026 |
Germaine Laboratories, Inc. |
Requests FDA to exempt devices classified as "Method, Metallic Reduction, Glucose (Urinary, Non Quantitative)" in 21 CFR 862.1340, from the premarket notification requirement (510(k)) |
03/21/16 |
|
|
| FDA-2016-P-0159 |
Biorex Labs LLC |
Requests FDA to exempt devices classified as "Method, Metallic Reduction, Glucose (Urinary, Non Quantitative)" in 21 CFR 862 .1340, from the premarket notification requirement (510 (k)) |
01/07/16 |
|
07/01/16 |
| FDA-2016-P-1303 |
Charles G. Brown |
To Amend FDA Rule to Require Patient Labeling |
05/19/16 |
|
|
| FDA-2016-P-1398 |
Hooman Noorchashm, MD, PhD |
Requesting that the FDA revoke FDA clearance of the Pneumoliner Containment System for use with Power Morcellators |
05/31/16 |
|
|
| FDA- 2016-P-2559 |
Jonathan W. Emord, et. al. Emord and Associates, P.C. |
Requests that the FDA either promulgate a final regulation making electroconvulsive therapy (ECT) devices banned devices or maintain the Class III classification of the devices and issue a final order establishing the effective date for premarketapproval (PMA) for all ECT devices |
08/25/16 |
08/29/16 |
|
| FDA 2016-P-3195 |
Wood, Herron & Evens, L.L.P. |
Detaining the product manufactured or sold by Magnacoustics, Inc. |
10/06/16 |
10/06/16 |
|