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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  As a result some Web links (URLs) in the chart below are no longer valid.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  
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   12/03/03
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 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 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    
FDA-2006-P-0141 John D. Stephens, M.D. Banning of Accu-Gender Blood Test 09/11/06   10/12/06
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   09/08/09
FDA-2007-P-0464 Ralph D. Childs Electronic Product Radiation Control 10/03/07   09/08/09
 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 11/26/08
FDA-2008-P-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-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 8/6/2008    
FDA-2008-P-0531 University of Virginia Health System Petition to Ban Cornstarch Powder on Medical Gloves
 09/26/08    
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 11/4/2008    
FDA-2008-P-0630 The Prescription Project Take Action to Address the Growth of Online/Internet Advertising of Drugs and Devices 12/8/2008    
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 12/9/2008    
 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 1/14/2009    
FDA-2009-P-0094 American Association for Health Freedom Consider the Potential Risks of Exposure to Bisphenol-A for Dental Applications 2/18/2009    
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
2/18/2009    
FDA-2009-P-0117 Kimberly-Clark Health Care Petition to ban Cornstarch Powder on Medical Gloves 2/26/2009    
FDA-2009-P-0150 Arthur K. Yellin Create a Separate Classification for Gloves used in Preparing and Administering Chemotherapeutic Drugs 3/18/2009    
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 5/25/2009    
FDA-2009-P-0282 Pepper Hamilton, LLP Petition for FDA to Detain devices within the "Remote Medication Management Systems" device type 6/19/2009    
FDA-2009-P-0357 International Academy of Oral Medicine and Toxicology Petition to Ban Dental Amalgam or Classify the Device as Class III 7/28/2009    

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

    
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