• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

CDRH Petitions

We have recently redesigned the FDA Web site. As a result some Web links (URLs) in the chart below are no longer valid. If you find a link that does not work, please copy the petition number and enter it at www.regulations.gov.

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.

Additional information about petitions can be found on the page: Making Your Voice Heard at FDA: How to Comment on Proposed Regulations and Submit Petitions

Note: All documents are in PDF format.

CDRH Petitions

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  
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-0149 Washington Legal Foundation (WLF)
 
Medical Device Assays Developed by Clinical Laboratories Strictly for In-House (Homebrew) 10/02/06    
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    
FDA-2008-N-0163/PRC Citizens for Health, et al. Reconsider the Classification of Dental Amalgam as Class II 09/03/09    
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    
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    
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  
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    
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  
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    
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    
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    
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  
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-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    
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    
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    

Additional petition information can be found at the FDA Dockets website.