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  1. CDRH FOIA: How to Get Records from CDRH

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 07/15/1994 03/21/2003 12/02/2004
FDA-2001-A-0410 PA Department of Health Collection kits marketed by the Osborn Group, Inc. 08/30/2001 04/04/2002  
FDA-2001-P-0128 Bio-Rad Laboratories Permit mfrs. to allow the use of symbols in IVD labeling 07/10/2001 09/11/2002 11/18/2003
FDA-2001-P-0158 Association of Disposable Device Manufacturers Regulate reprocessed single use as reusable medical devices 08/15/2001 02/11/2002 12/29/2004
FDA-2001-P-0389 Kyper & Associates LLC To revoke compliance program 7383.003 for class III 510(k) pre-amendment devices 09/05/2001   03/13/2003
FDA-2002-P-0079 Russell J. Thomsen, M.D. Over-the-counter sales for hand-held Doppler Fetoscopes 07/29/2002 01/24/2003 06/19/2003
FDA-2002-P-0132 Zuckerman, Spaeder LLP To post responses to warning letters on the Internet 10/30/2002 03/27/2003 10/21/2003
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. 06/12/2002 03/27/2003 10/21/2003
FDA-2002-P-0255 St. Jude Medical Electronic labeling programmer/computer that implanted pulse generator 02/26/2002 09/11/2002 09/29/2003
FDA-2002-P-0437 Richard Strolworthy To amend the FDA 510(k) policy to include disclosure & labeling requirements 10/08/2002   04/16/2003
FDA-2003-P-0014 Tim Milburn, O.D. Contact Lens 06/24/2003   06/28/2004
FDA-2003-P-0105 Mettler Electronics Corp. FDA to revoke the medical device tracking order for invusion pumps 03/14/2003   05/28/2003
FDA-2003-P-0124 Chemically Associated Neurological Disorders Silicone gel-filled breast implants. 11/18/2003   12/04/2003
FDA-2003-P-0166 Associated Pharmacologists & Toxicologists Revoke approval for marketing of menstrual cups 04/18/2003   11/18/2003
FDA-2003-P-0184 Russel J. Thomsen, M.D. Requesting FDA to reconsider decision on Over-the-counter sales for hand-held doppler fetoscopes 09/25/2003 03/08/2004 06/14/2004
FDA-2003-P-0266 Endotec, Inc. Revoke the AIP on Endotec 10/10/2003 03/26/2004  
FDA-2003-P-0275 Etymotic Research, Inc. Over-the-counter Hearing Aids 08/12/2003   02/13/2004
FDA-2003-P-0278 Committee for Truth in Psychiatry Maintain ECT in Class III 12/10/2003   09/03/2004
FDA-2003-P-0342 GudHear, Inc. Professional and Patient Labeling for Hearing Aid Devices 08/12/2003   02/13/2004
FDA-2003-P-0403 Peter M. Rothenberg, MD, MA Exemption for an accessory to an electrode cable 06/30/2003   08/14/2003
FDA-2003-P-0411 National Organization for Women. Silicone gel-filled breast implants 11/07/2003   12/03/2003
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. 07/28/2004   11/03/2005
FDA-2004-P-0350 Gastroparesis and Dysmotilities Association Transfer Enterra Therapy from HUD to PMA 02/26/2004   11/04/2004
FDA-2004-P-0100 City of Arlington Texas Advisory opinion regarding automatic eternal defibrillators 08/09/2004   03/15/2005
FDA-2004-P-0103 BioRad Issue a written opinion stating that unified, truthful labeling for domestic and international sales is lawful 02/11/2004 07/08/2004 05/02/2007
FDA-2004-P-0164 Billy Pierson Med Watch complaint 01/07/2004   04/06/2004
FDA-2004-P-0203 Northwest Community Hospital FDA to take action toward medical device manufacturers regarding the interchangeability of medical devices with one another 08/18/2004    
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. 07/26/2004   02/25/2005
FDA-2004-P-0285 Endotec, Inc Request to reclass from III to II the Non-Constrained Mobile Bearing Ankle Prostheses. 10/13/2004 04/11/2006 11/21/2006
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 07/01/2004 09/15/2004  
FDA-2004-P-0407 Etymotic Research Inc. TV-TIP Sound Amplifier (WORD) 01/22/2004   07/20/2004
FDA-2004-P-0417 Philips Medical Systems Exemption from the medical devices tracking requirements for Heartstream automated external defibrillators  04/06/2004 07/23/2004 10/29/2004
FDA-2005-A-0248 Bill Pierson Requesting the FDA for an opinion regarding hip joint metal constraint 01/07/2005   08/02/2005
FDA-2005-A-0419 Jaeckle Fleischmann & Mugel LLP Concerns on 510(k) for a Medical Device 04/05/2005   11/08/2005
FDA-2005-P-0008 Planmed Oy Reclassification of Full Field Digital Mammography from class III to class II 12/21/2005 04/18/2006  
FDA-2005-P-0052 RS Medical Requesting that FDA reclassify non-invasive bone growth stimulator from Class III to Class II 03/30/2005 08/01/2005 04/02/2007
FDA-2005-P-0063 S. Maher Reclassification metal/metal hip prostheses from Class III to Class II 09/30/2005 03/15/2006 06/29/2006
FDA-2005-P-0067 Zuckerman Spaeder LLP Requesting disapproval of the silicone-gel filled breast implant products.  05/24/2005 11/10/2005 11/17/2006
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 05/31/2005 11/09/2005 07/03/2007
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 11/10/2005   07/11/2011
FDA-2005-P-0197 C. Brown, Consumers for Dental Choice Initiate Transfer of Responsibility to Regulate/Classify Dental Amalgam  11/15/2005   10/26/2006
FDA-2005-P-0205 Medtronic Xomed Request to reclassify Class III to II for the Lamicel Osmotic Cervical Dilator 07/26/2005    
FDA-2005-P-0251 Life Measurement Operations Requesting a change of classification of Sonamet Body Composition Analyzer 05/25/2005 10/21/2005 07/02/2007
FDA-2005-P-0261 International Myopia Prevention Association Misbranding of prescription distance glasses and contact lenses 05/02/2005 10/28/2005 08/02/2006
FDA-2005-P-0262 CooperSurgical, Inc. Requesting to reclassify the MCCue CUBA Clinical Ultrasonic Bone Sonometry System  10/26/2005   04/05/2006
FDA-2005-P-0324 Wright Medical Technology Inc. To deny approval of Smith & Nephew premarket approval application for the Birmingham Hip Resurfacing System. 11/01/2005   05/09/2006
FDA-2005-P-0375 C. Brown, Consumers for Dental Choice Withdraw Draft Regulation on Mercury Amalgam 11/16/2005   10/26/2006
FDA-2005-P-0382 World Wide Medical Technologies FDA safeguard kits for treatment of prostate cancer that use bone wax 02/23/2005 08/16/2005 05/22/2009
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 09/05/2006   01/08/2007
FDA-2006-P-0022 Bayer Corporation Removal of Labeling for Medisense Precision Advanced Diabetes Management System 08/08/2006   09/06/2006
FDA-2006-P-0024 Chemically Associated Neurological Disorders Stay the approvable of any PMA's for silicone gel-filled breast implants  04/10/2006   11/17/2006
FDA-2006-P-0074 American Association of Neurological Surgeons Cranial Orthoses exempt from Class II  07/06/2006   12/26/2007
FDA-2006-P-0075 Michael Patterson Stop approving LASIK devices or Ban Lasik Devices 12/18/2006   07/20/2007
FDA-2006-P-0088 Michael Patterson Stop LASIK Due to Informed Consent Problems 05/19/2006 11/06/2006 07/20/2007
FDA-2006-P-0140 Regulatory & Clinical Research Institute Reclassification of Tissue Adhesive for Soft Tissue 02/10/2006 08/23/2006 05/05/2008
FDA-2006-P-0141 John D. Stephens, M.D. Banning of Accu-Gender Blood Test 09/12/2006   10/12/2006
FDA-2006-P-0143 Public Citizen Revoke FDA's Prior Approval of Vagus Nerve Stimulation(VNS) for management of Treatment-resistant Depression (TRD)  09/07/2006 03/02/2007 05/25/2020
FDA-2006-P-0149 Washington Legal Foundation (WLF) Medical Device Assays Developed by Clinical Laboratories Strictly for In-House (Homebrew)  10/02/2006   07/31/2014
FDA-2006-P-0277 Michael Patterson Stop all approvals of medical devices used for implantable lens implants 12/18/2006   07/20/2007
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 06/27/2006 12/22/2006 03/05/2007
FDA-2006-P-0336 Regeneration Technologies, Inc Bone Heterograft Reclassification 08/17/2006 10/29/2007 10/25/2007
FDA-2006-P-0337 Alcohol Monitoring System Petition for the SCRAM Bracelet  01/26/2006    
FDA-2006-P-0347 Michael Patterson Enforce the single-use requirement for all Microkeratomes and their components used by Lasik 05/19/2006 11/06/2006 07/20/2007
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." 09/19/2006 03/16/2007 02/05/2008
FDA-2006-P-0460 Banner & Witcoff, LTD Initiate Administrative proceedings and enjoining the unlawful sale and distribution by International Tan Markers, Inc. 04/18/2006   10/04/2006
FDA-2007-A-0163 Alston & Bird LLP Advisory Opinion request for Mandatory Black Box warnings on all Bovine Thrombin Products 08/27/2007 02/20/2008 06/02/2008
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 04/24/2007    
FDA-2007-P-0005 Association of Medical Device Reprocessors FDA to Take Action to Subject Certain Cardiac Surgery Devices to 510(k) Requirements 05/01/2007 10/29/2007  
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 07/09/2007 12/06/2007  
FDA-2007-P-0116 Dean Andrew Kantis Take steps to insure the safety of Americans regarding the misuses of Lasik 01/05/2007    
FDA-2007-P-0117 Health Care Without Harm Regulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers 08/14/2007 01/22/2008  
FDA-2007-P-0118 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 08/27/2007   09/08/2009
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)) 05/22/2007    
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 12/12/2007   08/08/2008
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 06/08/2007 12/06/2007  
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 12/17/2007   03/30/2010
FDA-2007-P-0464 Ralph D. Childs Electronic Product Radiation Control 10/03/2007   09/08/2009
FDA-2008-A-0619 Jeffrey K. Shapiro Request for Section 9 Limitations on 510(k) Exemption Advisory Opinion 12/01/2008 07/06/2009 03/15/2011
FDA-2008-P-0066 Christopher L. Jones, et al. Request enforcement concerning Computed Tomography sytems 01/29/2008   09/15/2009
FDA-2008-P-0159 Missouri State Board of Examiners for Hearing Instrument Specialists Application for Exemption from Preemption of Device Requirements 03/10/2008    
FDA-2008-P-0196 Carmel Pharma Withdraw Teva 510(k)s 03/25/2008 08/20/2008 04/04/2011
FDA-2008-P-0197 W.J. Kennick Tomatis Electronic Ear 03/26/2008 09/12/2008 11/26/2008
FDA-2008-P-0252 Richard W. Treharne, PhD Withdraw FDA Policy on Establishing Preamendments Status 04/21/2008   12/21/2010
FDA-2008-P-0282 Pneumex, Inc. Request that FDA reclassify Pneumex's device known as the Pneu-Vibe-Trac device from 510(k) requirements 05/05/2008   06/13/2008
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 05/28/2008   07/16/2009
FDA-2008-P-0353 Fuerst, Humphrey, Ittleman, PL Petition for Stay of Action under 21 CFR 10.35 (concerning HairMax LaserComb medical devices) 06/18/2008   10/03/2008
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.  07/09/2008 02/23/2009  
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 08/06/2008 07/06/2009 04/19/2011
FDA-2008-P-0531 University of Virginia Health System Petition to Ban Cornstarch Powder on Medical Gloves 10/02/2008 03/09/2009 04/04/2018
FDA-2008-P-0533 Fuerst, Humphrey, Ittleman, PL Take Action to Address the Growth of Online/Internet Advertising of Drugs and Devices 09/26/2008 03/26/2009  
FDA-2008-P-0585 Elliot Farber Artificial Eyes Lubricant 11/05/2008 07/20/2009  
FDA-2008-P-0630 The Prescription Project Take Action to Address the Growth of Online/Internet Advertising of Drugs and Devices 12/08/2008 05/31/2009  
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 12/09/2008 06/15/2009 07/31/2014
FDA-2009-M-0101 Orthopedic Surgical Manufacturers Association (OSMA) Petition of Reclassification of Pedicle Screw Spinal Systems (Certain Uses) 08/09/2009   06/15/2017
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 01/14/2009    
FDA-2009-P-0094 American Association for Health Freedom Consider the Potential Risks of Exposure to Bisphenol-A for Dental Applications 02/18/2009 08/10/2009 05/26/2022
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  02/18/2009 06/02/2010  
FDA-2009-P-0117 Kimberly-Clark Health Care Petition to ban Cornstarch Powder on Medical Gloves 02/26/2009   10/16/2017
FDA-2009-P-0150 Arthur K. Yellin Create a Separate Classification for Gloves used in Preparing and Administering Chemotherapeutic Drugs 03/18/2009   08/24/2010
FDA-2009-P-0207 Thomas Quinn Request for Immediate Class One Recall of Philips Medical Devices 05/05/2009 10/27/2009 09/27/2013
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 05/29/2009   05/18/2010
FDA-2009-P-0282 Pepper Hamilton, LLP Petition for FDA to Detain devices within the "Remote Medication Management Systems" device type 06/19/2009   12/10/2009
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 07/01/2009 12/11/2009 05/04/2020
FDA-2009-P-0357 International Academy of Oral Medicine and Toxicology Petition to Ban Dental Amalgam or Classify the Device as Class III 07/28/2009 01/21/2010 01/27/2015
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 07/29/2009   05/19/2011
FDA-2009-P-0437 Edward Manougian Testing Methods for products to be used by the lay public in emergency situations 03/07/2010   08/24/2010
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 12/15/2009   04/10/2010
FDA-2009-P-0596 VQ OrthoCare Patient-Centered Solutions Reverse the 510(k) Approval for J-Stim 1000 12/16/2009 06/16/2010  
FDA-2009-P-0610 Mothers Against Mercury, Titus Hillis Reynolds Love Formally ban the use of Encapsulated Mercury Fillings as a Dental Restorative Measure 09/22/2009 08/26/2010 01/27/2015
FDA-2010-A-0154 R. Sheridan Consulting, LLC Request for an Advisory Opinion Concerning the Protection of Human Subjects 03/15/2010    
FDA-2010-N-0268 Consumers for Dental Choice To remove barriers preventing consumers from testifying at Dental Products Panel Meeting 10/04/2010   04/18/2011
FDA-2010-P-0045 Richard Edlich Remove the consumer report "Medical Glove Powder Report" from the FDA website. 01/19/2010   04/04/2018
FDA-2010-P-0052 Dr. Richard Edlich Remove Cornstarch Powder from Medical Gloves Because It Promotes the Growth of Cancer 01/20/2010   04/04/2018
FDA-2010-P-0056 Richard Edlich Prepare Informed Consent Brochures that Dentists must give to their Patients who Receive Dental Restorations 01/20/2010 08/26/2010 04/10/2018
FDA-2010-P-0339 Richard Edlich Require the Use of Powder Free Double Glove Hole Indicator System 06/23/2010   01/31/2012
FDA-2010-P-0352 Richard Edlich Revise Classification of Powdered Exam and Surgical Gloves 06/30/2010   04/04/2018
FDA-2010-P-0359 Mark Heller/ Goodwin Procter LLP Petition Requesting the Reclassification of Hemostatic Devices 07/06/2010 12/10/2010  
FDA-2010-P-0392 Richard Edlich Request to Make Final Decision on Petition to Ban Glove Powder 07/15/2010   04/04/2018
FDA-2010-P-0397 Richard Edlich Ban the Use of Cornstarch Powder in Surgical Gloves in In Vitro Fertilization Labs 07/22/2010   04/04/2018
FDA-2010-P-0401 Steve Gupta, M.D. Revoke Alair PMA Approval 07/27/2010 01/18/2011 12/02/2011
FDA-2010-P-0446 Richard Edlich Require Warning Label that Glove Hole Leakage rate is 1.5% on each surgical glove and packaging 08/20/2010   01/31/2012
FDA-2010-P-0489 Dr. Richard Edlich Establish Guidelines for Responding to a Citizen Petition 09/14/2010   04/04/2018
FDA-2010-P-0520 Extremity Innovations, Inc Reclassification Petition for Injectable Silicone 10/01/2010 03/09/2011 12/15/2011
FDA-2010-P-0559 Ben Z. Beiski GenNarino Transcutaneous Electrical Nerve Stimulation Intraoral Device for Xerostomia Relief 12/10/2010   09/23/2014
FDA-2010-P-0580 Ralph McBride Clarify Approval of Medronic Insulin Pump (P980022/S13) 11/10/2010 04/14/2011 09/23/2010
FDA-2010-P-0592 Dr. Richard Edlich Ban Sale of Liquid Mercury 11/17/2010 06/02/2011 08/12/2011
FDA-2010-P-0610 Dr. Richard Edlich Revise Classification of Dental Restorative Materials & Liquid Mercury 11/23/2010 06/02/2011 04/10/2018
FDA-2010-P-0617 Dr. Richard Edlich Ban Dental Amalgam (Severe Diseases) 11/24/2010 06/02/2011 04/10/2018
FDA-2010-P-0619 Dr. Richard Edlich Ban Dental Amalgam (Effects on Pregnant Women/Fetus) 11/29/2010 06/02/2011 04/10/2018
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 07/25/2011   11/21/2011
FDA-2011-N-0504 Tracey B. Kirsch, El ectromedical Products International, Inc. Reclassification of Cranial Electrotherapy Stimulator (CES) 08/22/2011   12/20/2019
FDA-2011-P-0022 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 01/07/2011 07/07/2011 10/26/2016
FDA-2011-P-0032 Anika Therapeutics Reconsideration of Denial of Approval of Pre-Market Application P090031 via Independent Advisory Committee Review 01/25/2011   03/24/2011
FDA-2011-P-0083 Pharmacists Planning Service, Inc. (PPS) Remove Nonoxynol-9 (N-9) in Condoms from USA Distribution 02/09/2011 07/28/2011  
FDA-2011-P-0150 Mike Sammon, SureTek Medical Enforcement of Premarket Notification Requirements Regarding Single-Use Devices 03/08/2011 08/08/2011 01/24/2020
FDA-2011-P-0151 Brian C. Mandingo Requesting Enforcement Against Church of Scientology for E-Meter 03/08/2011    
FDA-2011-P-0290 Northeast Scientific/Mitchell Fuerst, Esq. Agency Decision on Premarket Notification 510 (k) K090661 04/20/2011   08/15/2011
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 05/02/2011 10/20/2011 10/16/2017
FDA-2011-P-0355 Joseph V. Gulfo, M.D., MELA Sciences Request to Enforce 10/20/2004 Sec. 520(g)(7) Protocol Agreement 05/09/2011   04/11/2011
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" 05/17/2011   03/23/2012
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 05/31/2011 11/03/2011 12/19/2013
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 06/12/2011 12/05/2011 11/19/2019
FDA-2011-P-0475 Dr. S. Albert Edwards Investigate Edwards Lifesciences, Northwestern University IRB and Dr. Patrick McCarthy and Annuloplasty Rings 06/14/2011 12/02/2011 02/27/2012
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 06/14/2011 12/02/2011 12/09/2019
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 06/30/2011   02/12/2012
FDA-2011-P-0552 Robert Wagner Request to Issue Regulations Related to Outdoor Luminaires 07/19/2011   12/16/2011
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 08/10/2011 02/15/2012  
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 08/26/2011 02/10/2012 05/01/2014
FDA-2011-P-0660 Robert J. Michalik, Esq. RAC, RegulatoryPro.com Request to Amend Regulation Regarding Absorbable Hemostatic Devices (21 CFR 878.4490) 09/09/2011 02/07/2012  
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 10/21/2011 04/12/2012 10/28/2013
FDA-2011-P-0804 Richard Keller, Bruno Independent Living Aids, Inc. Exempt Stairlifts (Stairway Chairlifts) from Premarket Notification Requirements 11/07/2011   12/03/2012
FDA-2011-P-0820 G. Scott Crowther, PE Reconsider Dose of Mercury Released From Dental Amalgam & Ban Dental Amalgam and Its Components 11/09/2011 05/07/2012  
FDA-2011-P-0851 Sharon Starowicz, Orthopedic Manufacturers Assoc. Reclassification to FDA RE: 513(e) Posterior Cervical Pedical and Lateral Mass Screws 11/23/2011   05/06/2019
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 12/02/2011 05/03/2012 12/03/2012
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 12/22/2011 05/18/2012 08/08/2012
FDA-2012-N-0378 BioElectronics Corporation Effective Date of Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses 07/23/2012   11/27/2014
FDA-2012-P-0040 Fischer Surgical Requested Review of NSE Response to 510(k) Submission K110734 01/10/2012   02/23/2012
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 02/09/2012   03/02/2012
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 02/13/2012 08/09/2012 04/13/2020
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  03/09/2012   12/20/2019
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) 03/15/2012    
FDA-2012-P-0493 Leroy Leslie Hamilton, Ph.D. Request to Reclassify Cranial ElectrotherapyStimulator from Class III to Class II 05/16/2012   12/20/2019
FDA-2012-P-0747 Leroy Leslie Hamilton Request Commissioned to Conduct Impartial Investigation Regarding From FDA 3429 General Device Classification Questionnaire 07/10/2012 01/04/2013 03/04/2013
FDA-2012-P-0963 Charles J. Zimmerer Action Regarding Manufacturing and Use of Blood Nutrition Software 09/07/2012 03/19/2013  
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 09/25/2012   12/03/2013
FDA-2012-P-1107 Hogal Lovells for FzioMed Petition for Reconsideration--Denial of FzioMed, Inc.'s Premarket Approval Application for Oxiplex Gel  11/05/2012   03/19/2015
FDA-2012-P-1155 DEKA Research & Dev. Corp. Petition for Reclassification of Stair-Climbing Wheelchairs to Class II  11/20/2012   01/27/2014
FDA-2013-P-0048 James Reichmann Reclassify Drug Ondansetron (Zofran) 01/07/2013 07/03/2013 10/27/2015
FDA-2013-P-0070 Ikaria, Inc. Rescind 510(k) Clearance for GeNo, LLC  01/14/2013 07/10/2013 08/26/2020
FDA-2013-P-0076 DuVal & Associates; Minnesota Medical Device Alliance Stay of Action in Process of Reviewing 510(k)'s  01/16/2013 07/03/2013 07/25/2014
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 02/15/2013   07/12/2023
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 02/26/2013   06/18/2021
FDA-2013-P-0615 California State Speech-Language Pathology and Audiology and Hearing Aid Dispensers Board Application for Exemption from Preemption of Device Requirements 05/21/2013    
FDA-2013-P-0667 American Clinical Lab Association Regulating Laboratory Developed Tests (LDTs) 06/04/2013 11/26/2013 07/31/2014
FDA-2013-P-0735 Mario Morais Support Chronic Cerebrospinal Venous Insufficiency (CCSVI) as an MS Treatment 06/11/2013   06/19/2014
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  08/01/2013   02/04/2023
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 & Reconsideration Petition 04/08/2013 02/05/2014 05/30/2020
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  08/13/2013   06/21/2020
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  09/12/2013 02/24/2014 06/02/2014
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)  10/25/2013 03/26/2014 03/07/2022
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  11/20/2013 03/07/2014 07/19/2017
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  12/23/2013 03/26/2014  
FDA-2014-P-0038 Jennifer Butsch, Riverain Technologies Request to Reclassify ClearRead+Detect, a CADe device, from Class III to Class II  12/18/2013 06/17/2014 06/04/2018
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 01/23/2014 07/07/2014  
FDA-2014-P-0112 NadaChair Petition requesting FDA to un-register and delist NadaChair and its products from those requiring registration or regulation under the statutes and provisions of the FDA 01/23/2014 03/22/2019  
FDA-2014-P-0143 Gail Gudmundsen Personal Sound Amplification Products  01/28/2014 07/14/2014 10/23/2021
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  01/30/2014 07/22/2014 03/27/2016
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  01/30/2014 07/22/2014 10/23/2021
FDA-2014-P-0231 Adaptive Engineering Inc. Exempt the Manually Operated Wheelchair Lift From the 510(K) Premarket Notification  02/24/2014   08/14/2014
FDA-2014-P-0283 Leroy L. Hamilton Revise Form FDA 3429 to Indicate the Appropriate Classificationof a Medical Device  03/06/2014   05/16/2014
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  03/10/2014   05/16/2014
FDA-2014-P-0427 Medicem Technology Reclassify Dilapan  04/10/2014   08/14/2014
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.  04/14/2014 05/30/2014 11/15/2016
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 05/20/2014    
FDA-2014-P-0687 Margaret Moline Requesting FDA to revoke import alerts EPFX device 10/31/2014 04/22/2014 08/17/2016
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  11/03/2014 04/30/2015 08/30/2016
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  06/17/2014 07/22/2014 10/23/2021
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 06/19/2014 12/17/2014 07/16/2019
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 06/20/2014 12/17/2014 07/16/2019
FDA-2014-P-0907 Citizens for Health, et al. Reconsider the Classification of Dental Amalgam as Class II 06/30/2014   01/27/2015
FDA-2014-P-0908 Moms Against Mercury, et al. Reconsider the Classification of Dental Amalgam as Class II 06/30/2014   01/27/2015
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  07/01/2014 12/23/2014 10/23/2021
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 10/23/2014 12/22/2014  
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) 10/02/2014 03/30/2015 05/22/2015
FDA-2015-M-1065 Reed Smith LLP Reconsideration of PMA Approval of AutoSPray Dural Sealant 09/14/2015 10/16/2015 12/18/2019
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. 01/05/2015 06/08/2015 09/05/2022
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" 01/06/2015   03/02/2015
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 01/09/2015   09/14/2023
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 01/24/2015   03/26/2015
FDA-2015-P-0703 Sarah Salem-Robinson Issue Ban on Laparascopic Power Morcellators 03/05/2015   12/30/2020
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 04/13/2015   10/09/2015
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  05/12/2015 11/15/2015 02/26/2020
FDA-2015-P-1924 Hunton and Williams LLP Requesting FDA issue an order declaring Zeltiq CoolSculpting System to be NSE 05/29/2015 10/08/2015 03/14/2016
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 07/07/2015 10/06/2015 01/29/2021
FDA-2015-P-2481 SweetSpot Diabetes Care, Inc. requesting reclassification of diabetes data management software devices from class II to class I 07/15/2015   11/07/2019
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 08/03/2015 03/11/2016 12/19/2018
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 08/05/2015    
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 08/25/2015 01/21/2016  
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 08/25/2015   09/29/2021
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 09/08/2015 06/21/2016 04/16/2018
FDA-2015-P-3365 Inrange Systems, Inc. Requests FDA to detain Life Integrating Technologies product Lumma 09/18/2015 12/16/2015 12/16/2015
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 10/16/2015 04/11/2016 08/02/2016
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 10/20/2015 04/19/2016 05/26/2022
FDA-2015-P-4945 Ryszard Rokicki Request FDA to order Bayer to use petitioners patented methodology on Essure 12/21/2015 03/14/2016 05/09/2018
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)) 01/07/2016   07/01/2016
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)) 03/21/2016   09/06/2016
FDA-2016-P-1115 Mostyn Law Firm Request the FDA to issue an immediate Class I recall of all BSC products made with counterfeit, Chinese resin. 04/06/2016 09/21/2016  
FDA-2016-P-1303 Charles G. Brown,  Requesting FDA to require patient labeling for dental amalgams 05/19/2016 11/17/2016 05/26/2022
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 05/31/2016 11/17/2016 12/30/2020
FDA-2016-P-1955 Mallinckrodt Pharmaceuticals Requesting the FDA to formally designate INOMAX and the company's 510(k) cleared specialized delivery system, the INOmax DSIR Plus, as a drug-device combination product pursuant to 21 C.F.R. § 3.2(e)  06/30/2016   11/23/2016
FDA-2016-P-2072 Pacific-Link Consulting Requesting FDA guidelines for the Optimal Dose and Pharmacokinetics for any Naloxone Containing Product Intended for the Emergency Treatment of Suspected Opioid Overdose in all settings (Including Non-Medical Settings) by Individuals 07/13/2016   12/08/2016
FDA-2016-P-2497 Clinical Decision Support Coalition Requested FDA to issue a guidance document 08/18/2016 02/02/2017  
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 08/25/2016 02/02/2017 12/21/2018
FDA-2016-P-3195 Wood, Herron & Evens, L.L.P. Requesting the FDA to detain the devices marketed as MagnaTouch MRI Music System, Genesis Ultra MRI Music System and MagnAlarm. 10/06/2016   02/28/2017
FDA-2016-P-3674 Consumers for Dental Choice, Charles G. Brown Requesting the FDA to warn against amalgam use in children, pregnant women, and other sensitive populations 11/02/2016 04/27/2017 05/26/2022
FDA-2016-P-4094 Adapt Pharma Operations Ltd Requesting FDA (CDER and CDRH) to require proposed generic versions of Intranasal to provide specific data to support interchangeability. 11/29/2016   04/21/2017
FDA-2016-P-4587 Mallinckrodt Pharmaceuticals Requesting the FDA (CDER and CDRH) to review the inhaled nitric oxide drug products and nitric oxide delivery systems 12/28/2016   05/26/2017
FDA-2017-P-0290 Malaysian Rubber Export Promotion Council (Embassy) Request the FDA to extend the effective date of a Final Rule (FDA-2015-N-5107) from January 18, 2017 to March 18, 2017 to allow shipments carrying lightly powdered gloves to make appropriate arrangements at the port of entry to either ship elsewhere or re-label and re-pack for distribution to non-medical markets in the United States. 01/17/2017   06/26/2017
FDA-2017-P-1002 INRange Systems, Inc. Petition requests FDA detain the device marketed as "LUMMA." 02/15/2017   09/22/2017
FDA-2017-P-1226 INRange Systems, Inc. Petition requesting FDA take action to protect patient safety by detaining the product manufactured or sold by PharmRight Corporation under the product name "Livi" 02/27/2017   09/25/2017
FDA-2017-P-2233 Mercury Free Dentistry Requesting the FDA to amend its mercury amalgam rule 74 FR 38686 to implement measures to end amalgam use in children under age 15, pregnant women and breastfeeding mothers. 04/07/2017 10/26/2017 05/26/2022
FDA-2017-P-2561 STL International, Inc., Neal Hartman, Regulatory Consultant § 513(e) Petition for Reclassification of Hang Ups InvertAlign 04/24/2017   06/18/2018
FDA-2017-P-3330 Anonymous Requesting FDA to reconsider or revoke 510K Pre-Market Notification K151763 05/23/2017 11/17/2017 01/28/2020
FDA-2017-P-3405 Michael Boggi Requesting the FDA to initiate rulemaking requiring home medical device manufacturers to protect against the mixing of two different individuals' data on a smart phone app or other similar software. 05/30/2017 11/02/2017 07/24/2018
FDA-2017-P-3413 Salter Labs Reclassification for the EtC02 Tracheal Tube Adaptor (airway adaptor) Device from Class II to Class I (510(k) exempt) 05/23/2017    
FDA-2017-P-3884 Riverain Technologies, LLC. 513(e) Petition for Reclassification for Riverain Technologies Clear Read - Detect CADe Device from Class III (PMA Approval P000041) to Class II 06/14/2017   06/04/2018
FDA-2017-P-4335 William Bonificio Request to Amend the Classification of Glutaraldehyde-based tooth desensitizers from devices to drugs, or revoke their current classification as devices 07/18/2017 04/16/2018 05/26/2021
FDA-2017-P-4939 Chul-Hi Park, Ph.D Requesting FDA to take Administrative Action to Prevent Certain Categories of New Devices from being cleared for marketing without sufficient proof of Safety and Effectiveness 08/14/2017 05/21/2018 10/12/2021
FDA-2017-P-5124 Hyman, Phelps & McNamara, PC Requesting FDA to Exempt OTC Denture Repair Kits a Class II Device from Premarket Notification Requirements of section 510(k) of the FDC Act. 08/22/2017   01/31/2018
FDA-2017-P-6663 Dr. S. Albert Edwards Requests that FDA Investigate Edwards Lifesciences' Marketing, in Interstate Commerce the Myxo ET Logix 5100, Annuloplasty Ring 5110, during 2007 to 2009 without approved 510k or PMA 11/27/2017 04/26/2018 05/25/2020
FDA-2018-P-0599 National Pediculosis Association, Inc. Requesting FDA to update the Website and other Educational Collateral for the LiceMeister Comb for the Management and Treatment of Head Lice 02/07/2018 09/26/2018 01/17/2020
FDA-2018-P-1469 Epstein Becker & Green, P.C. Requesting FDA from making a determination of certain subject devices' substantial equivalence to the NSS-2 BRIDGE (21 C.F.R. § 882.5896) without preclinical studies and at least one clinical trial. 04/10/2018 10/18/2018  
FDA-2018-P-2073 LMS Direct Research Foundation Requesting the FDA seriously revisit and reconsider the issue of banning all laproscopic and hysteroscopic power morcellators for all GYN surgeries. 05/30/2018 06/12/2018 12/30/2020
FDA-2018-P-3102 Richard M. Fleming, MD, JD Request that the FDA respond to the applicable pharmaceutical companies, mammography and nuclear camera producers to address profiting from the misinformation regarding redistribution of the Technetium-99m Isotopes Sestamibi and Tetrofosmin, address misinformation being promulgated by the nuclear camera companies reporting that their SPECT and PET cameras are "quantifying" disease. 08/08/2018   07/09/2019
FDA-2018-P-3372 Lynne Gauthier, PhD, The Ohio State University Requesting the FDA to Expand FDA 510(k) Exemption Status to all Small and Portable Sensors that can be used for Relaxation of Muscular Reeducation 09/05/2018   04/21/2021
FDA-2018-P-3709 Jennifer Nelson Requesting the FDA to Reconsider the issue of Banning and Recall all Permanent Cautery Instruments (Spatula and Hook) for all Da Vinci Robotic Surgeries 09/28/2018 03/04/2019 07/12/2022
FDA-2018-P-3806 Dr. Greg Grillo, DDS Requesting the FDA to Regulate Oral Moisturizer Products that are marketed for Mitigation, Treatment or Prevention of Dry Mouth and that Linger in the Mouth 10/05/2018 04/02/2019 11/09/2020
FDA-2018-P-3843  Hoomad Noorchashm, MD, Ph.D.  Requesting the FDA to Ban the use of Uncontained Laparoscopic Power Morcellators in Gynecological Operations 10/10/2018 06/24/2019 12/30/2020
FDA-2018-P-3896 Chul-Hi Park, Ph.D. Requesting the FDA to Prevent Certain Categories of New Devices from Being Cleared for Marketing without Sufficient Proof of Safety and Effectiveness for Staple Line Leaks 10/13/2018 04/11/2019 10/12/2021
FDA-2018-P-3951 Chul-Hi Park, Ph.D. Requesting the FDA to Implement a Retroactive Regulatory Action to Remedy Deficiencies found in the 510(k) Process for the Surgical Stapler Devices  10/18/2018 04/16/2019 10/12/2021
FDA-2018-P-4143 Aakash Agarwal Requesting the FDA Cease Clearing 510(k)s and approving PMAs for Reprocessing of Pedicle Screws and other Implantable Orthopedic Devices and Cease Clearing 510(k)s for Reusable Implantable Orthopedic Devices 10/31/2018 04/02/2017  
FDA-2019-P-1009 Rossman Law Group, PLLC Requests the Commissioner to make a determination under 21 U.S.C. 1604(b)(3) regarding whether Lima Corporate S.P.A. was Required to Register with the Secretary under 21 U.S.C. 360 and/or list the Hip Implant Device at issue with the Secretary under 21 U.S.C. 360(j) 03/04/2019   07/01/2019
FDA-2019-P-1800 Boditech Med Inc. Requests that FDA take all Administrative Actions Required for Reclassification from class III to class II of Medical Devices Associated with Product Code NCD (Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis) 04/14/2019 04/16/2019 04/16/2019
FDA-2019-P-2038 American Dental Association Requesting FDA pursuant to FD&C Act §302(a) [21 U.S.C. §332(a)], an Injunction against SDC from Manufacturing or Continuing to Manufacture and from Continuing to Distribute and Sell in Interstate Commerce SDC's Plastic Teeth Aigner and Dental Impression Material Products.  04/26/2019   05/30/2019
FDA-2019-P-3347 Sean Honard Requests that the FDA amendment to regulation 21 CFR §890.3690, Powered Wheeled Stretcher, to exempt the classification from premarket notification 07/11/2019   12/31/2019
FDA-2019-P-5048 Epstein Becker & Green, P.C. Requesting the FDA to refrain from asking a determination of certain subject devices' substantial equivalence to the IB-Stim (21 C.F.R. § 876.5340, product code QHH) without preclinical studies and at least one clinical trial establishing non-inferiority of the subject device to the IB-Stim in head-to-head evaluations. 10/29/2019 04/27/2020  
FDA-2020-P-0152 Hyman, Phelps & McNamara, P.C. on behalf of Coalition to Preserve Access to PGx Information In the Subject column insert the following: Petition regarding Pharmacogenetic (PGx) testing reports & allowing clinical labs to communicate gene-drug interactions, requests FDA to revise their Safety Communication & requests any other such policy communications to be done by rulemaking. 01/10/2020 06/08/2020  
FDA-2020-P-0725 GBUK Group Ltd., Dr. Steve Curran Requesting the FDA to Remove the Requirement for the Medical Devices and Accessories Contained within Premarket Submission for K170371 to be Supplied with Adequate Directions for Use. 02/11/2020    
FDA-2020-P-0734 GBUK Group Ltd., Dr. Steve Curran Request the FDA to Remove the Requirement for Adequate Directions for use to be Supplied with the Medical Devices and Accessories listed in Premarket Submission for K170900. 02/11/2020 07/18/2020  
FDA-2020-P-0893 Fisher Wallace Laboratories, Inc., Kelly Roman Requests that the FDA withdraw the Final Order regarding CES Devices (the "Final Order"), and to Convene a new Neurological Devices Panel of the Medical Devices Advisory Committee to review all Available Valid Scientific Evidence of Safety and Effectiveness Pertaining to CES Devices 02/18/2020 07/23/2020 08/30/2021
FDA-2020-P-0945 Dr. Ernest C. Chisena M.D., M.S., Orthopedic Attending Surgeon; Jahangir S. Rastegar, Ph.D., Associate Professor Mechanical Engineering Department Stony Brook Request the FDA to Force Exogen-Bioventus to Prove that Ultrasound is Responsible for Enhancing Fracture Healing as Claimed in their PMA 02/25/2020 07/18/2020  
FDA-2020-P-1003 John Coleman, M.A., M.S., PH.D. Requests that the FDA Initiate Rulemaking Procedures to Require Premarket Clearance for all Models of Fever Thermometers Sold OTC in the U.S. 02/28/2020 06/08/2020  
FDA-2020-P-1166 Michael P. Flammia, Eckert Seamans Cherin & Mellott, LLC Requesting the FDA to Immediately and Indefinitely Stay Both of the two Effective dates for its Final Regulation Banning Electrical Stimulation Devices ("ESDs") to Treat Self-injurious behavior ("SIB") or aggressive Behavior ("AB") 03/23/2020 03/27/2020 06/13/2022
FDA-2020-P-1181 Max D. Stern, Todd & Weld LLP Request the FDA Stay Both of the two Effective Dates of FDA's Final Regulation Banning Electrical Stimulation Devices used to treat Self-injurious or Aggressive Behavior (the "Final Rule" or "Ban") Published in the Federal Register on March 6, 2020. 03/23/2020 09/10/2020 06/13/2022
FDA-2020-P-1220 Pattanam Srinivasan, M.D., C Laser Inc. Requesting the FDA 1) Overrule the Denial Order and Remove Srilas 7 from Automatic Class III to be placed in Class II (or I); 2) Recognize Srilas 7 as a "Non Significant Risk" Device for the Purpose of a Clinical Study and 3) Recognize Srilas 7 as a Breakthrough Device in Patient's Best Interest Consistent with FDA Own Written Communication Dated October 28, 2010 Granting the Device Expedited Review Status was Received on 03/20/2020. 03/20/2020   07/17/2021
FDA-2020-P-1831 Meenal Kheterpal Requesting the FDA to issue a determination on class labeling for all currently approved hedgehog inhibitors products. 08/31/2020 02/26/2021  
FDA-2020-P-1864 Kambiz Tajkarimi Requesting FDA to refrain from granting a 510(k) clearance or any other premarket clearance or approval to the Augmenta penile implant. 09/11/2020 05/17/2021  
FDA-2020-P-2008 Philips Respironics Requesting FDA to issue an exemption from the device tracking requirements under 21 C.F.R. Part 821 for the Care Orchestrator. 09/23/2020 12/18/2020 09/14/2023
FDA-2020-P-2010 Philips Respironics Requesting FDA to issue an exemption from the device tracking requirements under 21 C.F.R. Part 821 for the Care Orchestrator Essence. 09/23/2020 12/18/2020 09/14/2023
FDA-2020-P-2060 Penn Avenue Law & Policy Requesting the FDA to take Additional Administrative Action with respect to the Agency's Policy on Screening and Surveillance Tests During the COVID‐19 Public Health Emergency. 10/08/2020 10/05/2021 09/10/2023
FDA-2020-P-2289 Consumers for - Loeb & Loeb, LLP and James N. Czaban Requests the FDA to refrain from issuing any Warning Letter, Untitled Letter, or "It Has Come to Our attention" (IHCTOA) letter, or from initiating any other form of enforcement action against manufacturer or marketer of Daily Wear Uniform (scrubs) 12/10/2020 05/20/2021 12/05/2022
FDA-2021-P-0424 Sam DeMarco Requesting that the FDA amend regulation 21 CFR §890.5150(b), Powered Patient Transport (all other power patient transport), to exempt the classification from premarket notification 05/03/2021   10/19/2021
FDA-2021-P-0445 Janice S. Lintz Requesting the FDA to standardize the naming of hearing aid features and develop a rating system using international ANSI standards for the various hearing aid features 05/11/2021   09/05/2022
FDA-2021-P-0582 James McKim, Ph.D., IONTOX, LLC Requests that FDA reconsider the final decision to decline to review EUA210385 in the public interest and in the interest of justice was received and processed under CFR 10.30  06/03/2021   08/28/2021
FDA-2021-P-1148 Marlene Keeling Requesting breast implant manufacturers and plastic surgeons who implant or explant breast implants to pay for heavy metal testing and oxidation states of platinum when a woman who has been implanted has been diagnosed with an autoimmune disorder, connective tissue disease, cancer including Breast Implant Associated Large Cell Lymphoma or has the symptoms of Breast Implant Illness and if a breast implanted woman is breastfeeding, breast milk must be tested for heavy metals and oxidation states of platinum 10/22/2021   03/15/2022
FDA-2021-P-1347 Douglas A. Wood, Founder and National Director, Americans for Responsible Technology Imminent hazard ruling by HHS concerning the current official policy of the FDA regarding the safety of human exposure to non-ionizing radiofrequency radiation 12/22/2021   05/23/2022
FDA-2022-P-0234 Katherine Price Snedaker, LCSW,
PINK Concussions
Requesting FDA rescind SyncThink, Inc.'s 510(k) clearance K202927 for EYE-SYNC Indications for Use (IFU) as an aid in the diagnosis of a concussion 07/27/2022 07/28/2022 11/06/2022
FDA-2022-P-0599 Steven A. Zecola Issue an Order regarding the practice of requiring neuropsychological testing prior to Direct Brain Stimulation surgery 04/15/2022    
FDA-2022-P-1065 Glycan Technologies, Inc. Ban the use of glycogen assays that employ centrifugation of homogenates of patient specimens prior to the amyloglucosidase degradation of glycogen 06/09/2022 11/29/2022 09/27/2023
FDA-2022-P-1151 Mark Baker, President Request FDA to regulate electromagnetic radiation in the visible portion of the spectrum emitted by products that use Light Emitting Diodes and that these regulations set restrictions on spatial non-uniformity, chip-level peak luminance and peak radiance, spectral power distribution, and square wave flicker and that the regulations be designed to protect the physical and psychological health, safety, comfort, and civil rights of those who are negatively impacted by LED light 06/13/2022 11/06/2022 05/24/2024
FDA-2022-P-1632 Randall Steinmeyer Requests that the FDA remove the Association for the Advancement of Blood & Biotherapies regulatory authority over DNA testing and transfer said authority to the American Society of Crime Laboratory Directors and halt the sale of the so-called motherless paternity tests. 07/21/2022 01/04/2023  
FDA-2022-P-2644 Leigh Spotten FDA take all administrative actions required for reclassification for the medical devices associated with Product Code OAY; FDA regulatory classification details of which as on May 17, 2019 10/25/2022    
FDA-2022-P-2724 Hooman Noorchashm MD, PhD Revoke the medical device classification of P4HB based products from Becton Dickinson and reclassify these to a "Biologicals" 11/01/2022 04/21/2023 05/27/2024
FDA-2022-P-3013 Hooman Noorchashm MD, PhD Refer Becton Dickinson and Company's deliberate concealment of a bacterial ingress and contamination breach defect, in that company's 510(k) cleared GENESIS line of Rigid Sterilization Containers, to the Department of Justice for violation of the False Claims Act 11/28/2022 05/25/2023  
FDA-2022-P-3053 Ombu Enterprises, LLC FDA make the UDI information a publicly available field in the MAUDE database and the Recall database 11/30/2022 03/20/2023  
FDA-2022-P-3201 Derry Anderson Requesting that the FDA issue via regulation, changes to 21 CFR 868.5470, with proposed language providing that "hyperbaric chambers shall comply with the FDA's recognized consensus standards for hyperbaric chambers, i.e. NFPA 99, Health Care Facilities Code (2021) and ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy (2019) and update the FDA's recognized consensus standards for hyperbaric chambers, product code "CBF" (21 CFR 868.5470), to the most recent editions of NFPA 99, Health Care Facilities Code (2021) and ASME PVHO-1, Safety Standard for Pressure Vessels for Human Occupancy (2019) 12/13/2022 06/08/2023  
FDA-2023-P-0203 Najam Azmat  Requests that the FDA immediately, on a fast-track mandate that a barrier attachment separating the wheel of the wheelchair from the propulsion rim be placed on all wheelchairs, existing as well as those being newly manufactured to prevent soiling of hands from ground contamination while propelling the wheelchair 01/19/2023 08/22/2023 04/08/2024
FDA-2023-P-0219 David Miller FDA issue a corrective recall requiring corrections to all BlueStar Hemodialysis Machines 01/20/2023    
FDA-2023-P-0233 Mark Baker, Soft Lights Foundation FDA issue 21 CFR Part 1040.41 to regulate electromagnetic radiation in the visible portion of the spectrum emitted by products that use Light Emitting Diodes  01/23/2023 06/30/2023 05/24/2024
FDA-2023-P-0422 Bradley Merrill Thompson, Epstein Becker & Green, P.C. (on behalf of Clinical Decision Support Coalition). Rescind the final CDS Guidance and repropose the guidance to follow the statutory language of subsection (o) of the Cures Act 02/06/2023    
FDA-2023-P-0916 Hooman Noorchashm Scrutinize or revoke 510(k), K162922, cleared for BD's GalaForm 3D {aka, GalaFlex 3DR), on grounds that the manufacturer deliberately failed to reveal its true design intent to market and distribute this device, primarily as an "internal bra" for breast reconstruction surgeries 03/13/2023 09/06/2023 05/27/2024
FDA-2023-P-1302 Yudi Liu Amend regulation Title 21, Code of Federal Regulations, Part 801.430, User Labeling for Menstrual Tampons, to require ingredient labeling affixed to the menstrual product or its package insert 04/03/2023    
FDA-2023-P-2115 Douglas A. Wood, Americans for Responsible Technology

Planning, conducting, coordinating, and/or supporting research, development, training, and operational activities to minimize the emissions of, and exposure of people to, unnecessary electronic product radiation [21 USC 360ii (a) (2) Studying and evaluating emissions of, and conditions of exposure to electronic product radiation and intense magnetic fields [21 USC 360ii (a) (4) Developing, testing and evaluating the effectiveness of procedures and techniques for minimizing exposure to electronic product radiation [21 USC 360ii (a) (5)

05/25/2023 11/12/2023  
FDA-2023-P-2032 Mark DuVal Update Sonex Health's SX-One MicroKnife 510(k) clearance letter (K192873), which is anticipated to expressly reference the device as a 510(k) exempt device under product code FZW 05/19/2023    
FDA-2023-P-2808 Barbara Evans Requesting withdrawal of FDA's CDS Guidance which subjects physicians' professional speech to content-based regulation violating the First Amendment to the U.S. Constitution 07/07/2023    
FDA-2023-P-1702 Lynn R. Webster/Michael C. Barnes Requests to (1) deem Bamboo's NarxCare software a misbranded device; (2) issue a Warning Letter to Bamboo; (3) commence mandatory recall procedures with respect to the NarxCare software; and (4) take any other prompt action the agency deems appropriate to prevent serious, adverse health consequences or death 05/01/2023   07/21/2023
FDA-2023-P-3131 Marlene Keeling Requesting breast implant manufacturers and plastic surgeons who implant or explant breast implants to pay for heavy metal testing and oxidation states of platinum when a woman who has been implanted has been diagnosed with an autoimmune disorder, connective tissue disease, cancer including Breast Implant Illness Associated Anaplastic Large Cell Lymphoma or has the symptoms of Breast Implant Illness, also, if a breast implanted woman is breastfeeding, breast milk must be tested for heavy metals and oxidation states of platinum 07/27/2023   09/26/2023
FDA-2023-P-3547 James O'Reilly Requesting mandatory recall of the consumer-use cardiac monitoring device product "BODY GUARDIAN" by Boston Scientific Corporation (BSC) and removal of this device product from further sale to elderly consumers until and unless adequate labeling 08/18/2023   11/12/2023
FDA-2023-P-3828 Mark Baker, Soft Lights Foundation Petition for rulemaking to issue CFR Title 21, Chapter I, Subchapter J, Part 1040.50 - LED Vehicle Lights 09/07/2023 03/01/2024 05/24/2024
FDA-2023-P-1928 Lars Noah FDA take administrative action to assert authority over guns and/or ammunition as devices under 21 U.S.C § 321(h) 05/15/2023 09/15/2023 06/12/2024
FDA-2023-P-4782 Hooman Noorchashm FDA audit the informed consent protocol for the multicenter clinical trial of robotic mastectomy in women with breast cancer at the University of Pennsylvania, and elsewhere 10/30/2023   06/10/2024
FDA-2023-P-4962 Hooman Noorchashm FDA Warn Patients About the Unknown and Inadequately Studied Effect of FDA-Regulated Mesh Devices, Implanted Off-Label in Cosmetic Mastopexy (So-Called "Internal-Bra”) Operations, On the Sensitivity of Standard Surveillance Mammography and Ultrasound for Detection of Breast Cancer 11/08/2023 05/01/2024  
FDA-2023-P-3879 Mark Baker, Soft Lights Foundation FDA issue 21 CFR Part 1040.60 – LED Street Lights to regulate electromagnetic radiation in the visible portion of the spectrum emitted by products that use Light Emitting Diodes for street lighting, and that these regulations set restrictions on spatial non-uniformity, chip-level peak luminance and peak radiance, dispersion characteristics, spectral power distribution, digital flicker, pulse width modulation, and that the regulations be designed to protect the physiological health, physical health, neurological health, psychological health, circadian rhythms, safety, comfort, cognitive functioning, vision, and civil rights of all individuals, especially those who are negatively impacted by LED radiation. 09/11/2023 03/01/2024 05/24/2024
FDA-2023-P-5044 Hooman Noorchashm FDA Determine Whether Galatea Surgical/Becton Dickinson’s Published Human Subject Experiments, Which Were Used to Promote Off-Label Use of GalaFLEX and Phasix Products in Breast Surgery, Were Performed in Compliance With the Food, Drug and Cosmetic Act’s Requirements For Investigational Use of FDA-Regulated Medical Devices 11/15/2023   04/30/2024
FDA-2013-P-0615 Annemarie Delmugnaio, Executive Officer Speech-Language Pathology, Audiology and Hearing Aid Dispensers Board State of California Requesting FDA for an Exemption from Federal Preemption of State and Local Medical Device Requirements pertaining to hearing aids 06/04/2012   08/31/2023
FDA-2008-P-0159 David F. Barrett, Missouri State Board of Examiners for Hearing Instrument Specialists Requesting FDA an Exemption from preemption of device requirements the provisions of Chapter 346 of the Revised Statutes of Missouri 03/10/2008   08/31/2023
FDA-2024-P-0279 McKenzie E. Cato, Hyman, Phelps & McNamara, P.C. Petition for reconsideration of the December 12, 2023, rescission by the FDA of the substantial equivalence determination for the Nautilus Nitrile Exam Gloves (K210496) and stay of the 510(k) rescission pending consideration of the request for reconsideration 01/11/2024   05/31/2024
FDA-2024-P-2215 Gloria Pesce Delfino, Metaltronica Spa, Via delle Monachelle, 66-00071, Pomezia (RM), Italy FDA reclassify the tomo digital mammography devices (product code OTE) to the same risk class and premarket submission type as the FFDM digital mammography (product code MUE) devices 05/06/2024    
FDA-2024-P-2242 David Behar, M.D. Request FDA to make CPAP (Continuous Positive Airway Pressure) machines available without prescription requiring that sellers of CPAP machines provide instruction manuals written at the 6th grade level of reading ability and illustrations of the set up 05/07/2024    
 
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