About FDA

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 As a result some Web links (URLs) in the chart below are no longer valid.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 #PetitionerSubjectDate
Filed
Date of
Interim
Response(s)
Completion
of Petition
FDA-1994-P-0023MiniMed TechnologiesImplantable infusion pump for insulin07/15/9403/21/0312/02/04
FDA-2001-P-0128Bio-Rad LaboratoriesPermit mfrs. to allow the use of symbols in IVD labeling07/10/0101/10/02
09/11/02
11/18/03
FDA-2001-P-0158Association of Disposable Device ManufacturersRegulate reprocessed single use as reusable medical devices08/15/0102/11/0212/29/04
FDA-2001-A-0410PA Department of HealthCollection kits marketed by the Osborn Group, Inc.08/24/0104/04/02 
FDA-2001-P-0389Kyper & Associates LLCTo revoke compliance program 7383.003 for class III 510(k) pre-amendment devices09/05/01 03/13/03
FDA-2002-P-0255St. Jude MedicalElectronic labeling programmer/computer that implanted pulse generator02/26/0209/11/0209/29/03
FDA-2002-P-0172Nocona General HospitalTo amend the MQSA standard and FOI act to allow facilities to respond and post responses to warning letters on the Internet.06/12/0203/27/0310/21/03
FDA-2002-P-0079Russell J. Thomsen, M.D.Over-the-counter sales for hand-held Doppler Fetoscopes07/29/0201/24/0306/19/03
FDA-2002-P-0437Richard StrolworthyTo amend the FDA 510(k) policy to include disclosure & labeling requirements10/08/02 04/16/03
FDA-2002-P-0132Zuckerman, Spaeder LLPTo post responses to warning letters on the Internet10/30/0203/27/0310/21/03
FDA-2003-P-0105Mettler Electronics Corp.FDA to revoke the medical device tracking order for invusion pumps03/14/03 05/28/03
FDA-2003-P-0166Associated Pharmacologists & ToxicologistsRevoke approval for marketing of menstrual cups04/18/03 11/18/03
FDA-2003-P-0014Tim Milburn, O.D.Contact Lens06/24/03 06/28/04
FDA-2003-P-0403Peter M. Rothenberg, MD, MAExemption for an accessory to an electrode cable06/30/03 08/14/03
FDA-2003-P-0275Etymotic Research, Inc.Over-the-counter Hearing Aids08/11/03 02/13/04
FDA-2003-P-0342GudHear, Inc.Professional and Patient Labeling for Hearing Aid Devices08/11/03 02/13/04
FDA-2003-P-0184Russel J. Thomsen, M.D.Requesting FDA to reconsider decision on Over-the-counter sales for hand-held doppler fetoscopes09/08/0303/08/0406/14/04
FDA-2003-P-0266Endotec, Inc.Revoke the AIP on Endotec10/10/0303/26/04 
FDA-2003-P-0411National Organization for Women.Silicone gel-filled breast implants11/03/03 12/03/03
FDA-2003-P-0124Chemically Associated Neurological Disorders

Silicone gel-filled breast implants.

11/18/03 12/04/03
FDA-2003-P-0278Committee for Truth in PsychiatryMaintain ECT in Class III12/10/03 09/03/04
FDA-2004-P-0164Billy PiersonMed Watch complaint12/22/03 04/06/04
FDA-2004-P-0407Etymotic Research Inc.TV-TIP Sound Amplifier (WORD)01/22/04 07/20/04
FDA-2004-P-0103BioRadIssue a written opinion stating that unified, truthful labeling for domestic and international sales is lawful02/06/0407/08/0405/02/07
FDA-2004-P-0407Gastroparesis and Dysmotilities AssociationTransfer Enterra Therapy from HUD to PMA02/26/04 11/04/04
FDA-2004-P-0417Philips Medical SystemsExemption from the medical devices tracking requirements for Heartstream automated external defibrillators
 
04/06/04 10/29/04
FDA-2004-P-0349Computerized Thermal Imaging Inc.Requesting FDA to permit CTI to supplement the administrative record in connection with CTI's PMA approval07/01/0409/15/0410/26/04
FDA-2004-P-0223Russel 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-0028Hyman, Phelps & McNamara, PCRequesting 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-0100City of Arlington TexasAdvisory opinion regarding automatic eternal defibrillators08/09/04 03/15/05
FDA-2004-P-0203Northwest Community HospitalFDA to take action toward medical device manufacturers regarding the interchangeability of medical devices with one another08/18/04  
FDA-2004-P-0285Endotec, IncRequest to reclass from III to II the Non-Constrained Mobile Bearing Ankle Prostheses.10/13/0504/11/06 
FDA-2005-A-0248Bill PiersonRequesting the FDA for an opinion regarding hip joint metal constraint
 
02/07/05 08/02/05
FDA-2005-P-0052RS MedicalRequesting that FDA reclassify non-invasive bone growth stimulator from Class III to Class II
 
02/09/0508/01/05Withdrawn
FDA-2005-P-0382World Wide Medical TechnologiesFDA safeguard kits for treatment of prostate cancer that use bone wax
 
02/23/0508/16/0505/22/09
 
FDA-2005-A-0419Jaeckle Fleischmann & Mugel LLPConcerns on 510(k) for a Medical Dental Device
 
04/05/05 11/08/05
FDA-2005-P-0261International Myopia Prevention AssociationMisbranding of prescription distance glasses and contact lenses
 
05/02/0510/28/0508/02/06
FDA-2005-P-0067Zuckerman Spaeder LLPRequesting disapproval of the silicone-gel filled breast implant products.
 
05/23/0512/05/0511/17/06
FDA-2005-P-0251Life Measurement OperationsRequesting a change of classification of Sonamet Body Composition Analyzer
 
05/23/0510/21/0507/02/07
FDA-2005-P-0070Scientific 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-0205Medtronic XomedRequest to reclassify Class III to II for the Lamicel Osmotic Cervical Dilator07/26/05  
FDA-2005-P-0136Public Citizen's Health Research GroupFDA to establish tighter regulations governing the process by which Medical Devices are reviewed and recalled11/10/0505/25/0607/11/11
 
FDA-2005-P-0063S. MaherReclassification metal/metal hip prostheses from Class III to Class II09/19/0503/15/06 
FDA-2005-P-0262CooperSurgical, Inc.Requesting to reclassify the MCCue CUBA Clinical Ultrasonic Bone Sonometry System 10/26/05 04/05/06
FDA-2005-P-0324Wright Medical Technology Inc.To deny approval of Smith & Nephew premarket approval application for the Birmingham Hip Resurfacing System.11/01/0510/31/0505/12/06
FDA-2005-P-0197C. Brown, Consumers for Dental ChoiceInitiate Transfer of Responsibility to Regulate/Classify Dental Amalgam 11/15/05 10/26/06
FDA-2005-P-0375C. Brown, Consumers for Dental ChoiceWithdraw Draft Regulation on Mercury Amalgam11/16/0510/26/06 
FDA-2005-P-0008Planmed OyReclassification of Full Field Digital Mammography from class III to class II12/21/0504/18/06 
FDA-2006-P-0337Alcohol Monitoring SystemPetition for the SCRAM Bracelet 01/25/06  
FDA-2006-P-0140Regulatory & Clinical Research InstituteReclassification of Tissue Adhesive for Soft Tissue02/09/0608/23/0605/05/08
FDA-2006-P-0024Chemically Associated Neurological DisordersStay the approvable of any PMA's for silicone gel-filled breast implants 04/10/06 11/17/06
FDA-2006-P-0460Banner & Witcoff, LTDInitiate Administrative proceedings and enjoining the unlawful sale and distribution by International Tan Markers, Inc.04/18/06 3/14/08
FDA-2006-P-0088Michael PattersonStop LASIK Due to Informed Consent Problems05/19/0611/06/0607/20/07
FDA-2006-P-0347Michael PattersonEnforce the single-use requirement for all Microkeratomes and their components used by Lasik05/19/0611/06/0607/20/07
FDA-2006-P-0287Robert Habig, PhD, Clinical & Laboratory Standards InstituteAmend practice of assessing the performance of medical device for determining in vitro susceptibility of bacteria or fungi to include CL SI06/26/0612/22/06
 
03/05/07
FDA-2006-P-0074American Association of Neurological SurgeonsCranial Orthoses exempt from Class II 07/06/0601/02/0712/26/07
FDA-2006-P-0022Bayer CorporationRemoval of Labeling for Medisense Precision Advanced Diabetes Management System08/08/06 09/06/06
FDA-2006-P-0336Regeneration Technologies, IncBone Heterograft Reclassification08/17/0610/29/07 
FDA-2006-P-0021Kerr CorporationUrge 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-0143Public CitizenRevoke FDA's Prior Approval of Vagus Nerve Stimulation(VNS) for management of Treatment-resistant Depression
(TRD)
 
09/06/06  
FDA-2006-P-0141John D. Stephens, M.D.Banning of Accu-Gender Blood Test09/11/06 10/12/06
 
FDA-2006-P-0149Washington Legal Foundation (WLF)Medical Device Assays Developed by Clinical Laboratories Strictly for In-House (Homebrew) 10/02/06 07/31/14
FDA-2006-P-0454Jerry StatonOrder 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."
 
09/19/0603/16/0702/05/08
FDA-2006-P-0149Washington Legal Foundation (WLF)
 
Medical Device Assays Developed by Clinical Laboratories Strictly for In-House (Homebrew)10/02/06  
FDA-2006-P-0075Michael PattersonStop approving LASIK devices or Ban Lasik Devices
 
12/18/06 07/20/07
FDA-2006-P-0277Michael PattersonStop all approvals of medical devices used for implantable lens implants12/18/06 07/20/07
FDA-2007-P-0116
 
Dean Andrew KantisTake steps to insure the safety of Americans regarding the misuses of Lasik
 
01/05/07  
FDA-2007-A-0279AFrame 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-0005Association of Medical Device ReprocessorsFDA to Take Action to Subject Certain Cardiac Surgery Devices to 510(k) Requirements05/01/0710/29/07 
FDA-2007-P-0120HiFi DNA TechPetitioner 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-0288Clinical & 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
 
06/08/0712/06/07 
FDA-2007-P-0115Clinical & Laboratory Standards Institute (CLSI)Request that CDRH allow 510(k) clearance of devices for antimicrobial susceptibility testing of Streptococcus pneumoniae with penicillin
 
06/29/0712/06/07 
FDA-2007-P-0117Health Care Without HarmRegulation or Guideline to Label Medical Devices that Leach DEHP Plasticizers
 
08/14/07  
FDA-2007-A-0163Alston & Bird LLPAdvisory Opinion request for Mandatory Black Box warnings on all Bovine Thrombin Products
 
08/24/0702/20/0806/02/08
FDA-2007-P-0118
FDA-2008-P-0066
Thomas J. QuinnStrict 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-0464Ralph D. ChildsElectronic Product Radiation Control10/03/07 09/08/09
 
FDA-2007-P-0184Judy Slome CohainRestore 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-0417Consumer's UnionRequire that all print and electronic advertisements, including Internet advertisements, for implantable devices such as knee, hip, heart valves, cosmetic implants, and other devices12/17/07 03/30/10
FDA-2008-P-0196Carmel PharmaWithdraw Teva 510(k)s03/25/0808/20/0804/04/11
FDA-2008-P-0197W.J. KennickTomatis Electronic Ear03/20/0809/12/0811/26/08
FDA-2008-P-0252Richard W. Treharne, PhDWithdraw FDA Policy on Establishing Preamendments Status04/21/08 12/21/10
 
FDA-2008-P-0282Pneumex, Inc.Request that FDA reclassify Pneumex's device known as the Pneu-Vibe-Trac device from 510(k) requirements04/17/08 06/18/08
FDA-2008-P-0159Missouri State Board of Examiners for Hearing Instrument SpecialistsApplication for Exemption from Preemption of Device Requirements
 
03/05/08  
FDA-2008-N-0163/PRCMoms Against Mercury, et al.Reconsider the Classification of Dental Amalgam as Class II09/03/09 01/27/15
FDA-2008-N-0163/PRCCitizens for Health, et al.Reconsider the Classification of Dental Amalgam as Class II09/03/09 01/27/15
FDA-2008-P-0319Lauranell H. BurchBan the use of all Refractive Surgery Lasers for LASIK Surgery and Acknowledge and Enforce Remedy for the Misbranding of lasers used for LASIK05/28/08 07/16/09
FDA-2008-P-0353Fuerst, Humphrey, Ittleman, PLPetition 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-0444Codonics, 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 relief08/06/08 04/19/11
FDA-2008-P-0531University of Virginia Health SystemPetition to Ban Cornstarch Powder on Medical Gloves
 
10/02/0803/09/09 
FDA-2008-P-0533Fuerst, Humphrey, Ittleman, PLTake Action to Address the Growth of Online/Internet Advertising of Drugs and Devices09/26/08  
FDA-2008-P-0585Elliot FarberArtificial Eyes Lubricant11/04/08  
FDA-2008-P-0630The Prescription ProjectTake Action to Address the Growth of Online/Internet Advertising of Drugs and Devices12/08/0805/31/09 
FDA-2008-A-0619Jeffrey K. ShapiroRequest for Section 9 Limitations on 510(k) Exemption Advisory Opinion12/1/0907/06/0903/15/11
FDA-2008-P-0638Genetech, 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 standards12/09/08 07/31/14
FDA-2009-P-0023Electro 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. Marketplace01/14/09  
FDA-2009-P-0094American Association for Health FreedomConsider the Potential Risks of Exposure to Bisphenol-A for Dental Applications02/18/0908/10/09 
FDA-2009-P-0105Williams Kherkher Hart Boundas, LLPPetition 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-0117Kimberly-Clark Health CarePetition to ban Cornstarch Powder on Medical Gloves02/26/09  
FDA-2009-P-0150Arthur K. YellinCreate a Separate Classification for Gloves used in Preparing and Administering Chemotherapeutic Drugs03/18/09 08/24/10
FDA-2009-P-0207Thomas QuinnRequest for Immediate Class One Recall of Philips Medical Devices05/05/0911/27/0909/27/13
FDA-2009-P-0253Scott A. TolchinPetition for FDA to Inspect LASIK Cinics to Ensure Compliance with 21 CFR 803, Subpart C User Facility Reporting Requirements05/25/09 05/18/10
FDA-2009-P-0282Pepper Hamilton, LLPPetition for FDA to Detain devices within the "Remote Medication Management Systems" device type06/19/09 12/10/09
FDA-2009-P-0305Hygeia II Medical Group, Inc.Petition Seeking Clarification and Review of Labeling for Breastpumps and Mother/Baby Products in Contact with Human Breastmilk07/01/09  
FDA-2009-P-0357International Academy of Oral Medicine and ToxicologyPetition to Ban Dental Amalgam or Classify the Device as Class III07/28/09 01/27/15
FDA-2009-P-0362
 
Ryszard RokickiRequest 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 Sterilization07/29/09 02/25/11
FDA-2009-P-0437Edward ManougianTesting Methods for products to be used by the lay public in emergency situations03/7/2010 08/24/10
FDA-2009-P-0593Grove Medical LLCRequest 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 Material12/15/09 04/10/10
 
FDA-2009-P-0596VQ OrthoCare Patient-Centered SolutionsReverse the 510(k) Approval for J-Stim 100012/16/09  
FDA-2010-P-0045Richard EdlichRemove the consumer report "Medical Glove Powder Report from the FDA website.01/19/10  
FDA-2010-P-0052Dr. Richard EdlichRemove Cornstarch Powder from Medical Gloves Because It Promotes the Growth of Cancer01/20/10  
FDA-2010-P-0056Richard EdlichPrepare Informed Consent Brochures that Dentists must give to their Patients who Receive Dental Restorations01/20/10  
FDA-2010-A-0154R. Sheridan Consulting, LLCRequest for an Advisory Opinion Concerning the Protection of Human Subjects03/11/10  
FDA-2010-N-0268Consumers for Dental ChoiceDental Products Panel Meeting10/04/10 04/18/11
FDA-2010-P-0339Richard EdlichRequire the Use of Powder Free Double Glove Hole Indicator System06/23/10 01/31/12
FDA-2010-P-0352Richard EdlichRevise Classification of Powdered Exam and Surgical Gloves06/30/10  
FDA-2010-P-0359Mark Heller/ Goodwin Procter LLPPetition Requesting the Reclassification of Hemostatic Devices07/02/1012/10/10 
FDA-2010-P-0392Richard EdlichRequest to Make Final Decision on Petition to Ban Glove Powder07/15/10  
FDA-2010-P-0397Richard EdlichBan the Use of Cornstarch Powder in Surgical Gloves in In Vitro Fertilization Labs07/22/10  
FDA-2010-P-0401Steve Gupta, M.D.Revoke Alair PMA Approval07/27/1001/18/1112/2/11
FDA-2010-P-0446Richard EdlichRequire Warning Label that Glove Hole Leakage rate is 1.5% on each surgical glove and packaging08/20/10 1/31/12
FDA-2010-P-0489Dr. Richard EdlichEstablish Guidelines for Responding to a Citizen Petition09/14/10
 
  
FDA-2010-P-0520Extremity Innovations, IncReclassification Petition for Injectable Silicone02/22/1003/09/1112/15/11
FDA-2010-P-0559Ben Z. Beiski

GenNarino Transcutaneous Electrical Nerve Stimulation Intraoral Device for Xerostomia Relief

12/10/10  
FDA-2010-P-0580Ralph McBrideClarify Approval of Medronic Insulin Pump (P980022/S13)11/10/1004/14/11 
FDA-2010-P-0592Dr. Richard EdlichBan Sale of Liquid Mercury11/17/1006/02/1108/12/11
FDA-2010-P-0610Dr. Richard EdlichRevise Classification of Dental Restorative Materials & Liquid Mercury11/23/10  
FDA-2010-P-0617Dr. Richard EdlichBan Dental Amalgam (Severe Diseases)11/24/10  
FDA-2010-P-0619Dr. Richard EdlichBan Dental Amalgam (Effects on Pregnant Women/Fetus)11/29/10  
FDA-2011-P-0022Waxler Regulatory Consultancy LLCLASIK01/07/1107/07/1106/23/14
FDA-2011-P-0022/PRCWaxler Regulatory Consultancy LLCRequest that FDA Withdraw Premarket Approvals for all LASIK Excimer Laser Devices & Issue a Voluntary Recall of These Devices - Reconsideration Petition9/2/20141/23/2015 
FDA-2011-P-0032Anika TherapeuticsReconsideration of Denial of Approval of Pre-Market Application P090031 via Independent Advisory Committee Review01/11/11
 
 03/24/11
FDA-2011-P-0083Pharmacists Planning Service, Inc. (PPS)Remove Nonoxynol-9 (N-9) in Condoms from USA Distribution02/09/11  
FDA-2011-P-0150Mike Sammon, SureTek MedicalEnforcement of Premarket Notification Requirements Regarding Single-Use Devices03/08/1108/08/11 
FDA-2011-P-0151Brian C. MandingoRequesting Enforcement Against Church of Scientology for E-Meter03/08/11  
FDA-2011-P-0290Northeast Scientific/Mitchell Fuerst, Esq.Agency Decision on Premarket Notification 510 (k) K09066104/20/11 08/15/11
FDA-2011-P-0331Michael A. Carome, M.D., Public Citizen Health Research GroupRequest to Ban Cornstarch Powder on Medical Gloves & Ban Use of All Natural Latex Rubber Medical Gloves05/02/1110/20/11 
FDA-2011-P-0355
 
Joseph V. Gulfo, M.D., MELA SciencesRequest to Enforce 10/20/2004 Sec. 520(g)(7) Protocol Agreement05/09/11  
FDA-2011-P-0374Lanny 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-0438Public Citizen Health Research GroupRequest to Ban the Marketing of, and to Recall Beside Assistant Bed Handles Manufactured by Bed Handles Inc. Models BA10W and BA10W-605/31/1111/03/1112/19/13
FDA-2011-P-0474Mark 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 Negative06/13/1112/05/11 
FDA-2011-P-0475Dr. S. Albert EdwardsInvestigate Edwards Lifesciences, Northwestern University IRB and Dr. Patrick McCarthy and Annuloplasty Rings06/14/1112/02/1102/27/12
FDA-2011-P-0479Dr. S. Albert EdwardsRequest to Investigate Placement of Annuloplasty Rings & Number of Deaths from Annuloplasty Rings for Past 5 Years06/14/1112/02/11 
FDA-2011-P-0497Daniel J. Popeo, Washington Legal FoundationRequest Use of Advice from IOM Committee That Fails to Comply with FACA's Fair Balance Requirement06/13/11 02/12/12
FDA-2011-P-0552Robert WagnerRequest to Issue Regulations Related to Outdoor Luminaires07/19/11 12/16/11
FDA-2011-A-0562Russell 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-0590Kim Witczak and William K. VaughanRequest Administrative Action to Improve Involvement of Patients & Consumers in Reporting of Adverse Drug and Device Events08/10/11  
FDA-2011-P-0641Michael Carome, Public Citizen's Health Research GroupRequest to Ban Marketing of Non-Absorbable Surgical Mesh Products Designed and Labeled for Transvaginal Repair of Pelvic Organ Prolapse08/26/1102/10/12 
FDA-2011-P-0660Robert J. Michalik, Esq. RAC, RegulatoryPro.comRequest to Amend Regulation Regarding Absorbable Hemostatic Devices (21 CFR 878.4490)09/09/1102/07/12 
FDA-2011-P-0777Thomas W. Nerney, Institute for Health Quality and EthicsRequest to Fully Implement and Enforce Mammogram Quality Standards Amendment Act of 199210/21/1104/12/1210/28/13
FDA-2011-P-0804Richard Keller, Bruno Independent Living Aids, Inc.Exempt Stairlifts (Stairway Chairlifts) from Premarket Notification Requirements11/07/11 02/04/13
FDA-2011-P-0820G. Scott Crowther, PEReconsider Dose of Mercury Released From Dental Amalgam & Ban Dental Amalgam and Its Components11/09/11  
FDA-2011-P-0851Sharon Starowicz, Orthopedic Manufacturers Assoc.Reclassification to FDA RE: 513(e) Posterior Cervical Pedical and Lateral Mass Screws11/23/11  
FDA-2011-P-0882Richard 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 Act12/02/1105/03/1203/04/13
FDA-2011-P-0923Michael A. Carome, M.D., Public Citizen's Health Research GroupRequest to Immediately Withdraw Approval of Humanitarian Device Exemption (HDE) Application for Wingspan Stent System
12/22/1105/18/1208/08/12
FDA-2012-P-0040Fischer SurgicalRequested Review of NSE Response to 510(k) Submission K11073401/10/12 02/23/12
FDA-2012-P-0137Robert L. Sheridan, R. Sheridan Consulting, LLCRequest 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 Documents02/09/12  
FDA-2012-P-0153IntertekRequest to Refrain From Taking Admin Action Against Intertek by Dismissing Them as Accredited Person for 510(k) Review Under FDAMA of 1997 Without Due Process02/13/1208/09/12 
FDA-2012-P-0260Fisher Wallace LaboratoriesRequest that Commissioner Investigate Actions Taken by CDRH Related to 8/8/2011 RE: Cranial Electrotherapy Stimulator (CES) Devices 03/09/12  
FDA-2012-P-0270Lawrence Paros, Neuro Fitness LLCRequest 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-0378BioElectronics CorporationEffective Date of Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses07/23/12  
FDA-2012-P-0493Leroy Leslie Hamilton, Ph.D.Request to Reclassify Cranial ElectrotherapyStimulator from Class III to Class II05/16/12  
FDA-2012-P-0747Leroy Leslie HamiltonRequest Commissioned to Conduct Impartial Investigation Regarding From FDA 3429 General Device Classification Questionnaire07/10/12 03/04/13
FDA-2012-P-0963Charles J. ZimmererAction Regarding Manufacturing and Use of Blood Nutrition Software09/04/1203/19/13 
FDA-2012-P-1026Christine Humphrey on behalf of Synergy Health ConceptsStay the Effective Date of Any Possible Disclosure Concerning the Issuance of 9/5/2012 Warning Letters09/25/12 12/03/13
FDA-2012-P-1107Hogal Lovells for FzioMedPetition for Reconsideration--Denial of FzioMed, Inc.'s Premarket Approval Application for Oxiplex Gel 11/05/12  
FDA-2012-P-1155DEKA Research & Dev. Corp.Petition for Reclassification of Stair-Climbing Wheelchairs to Class II 11/20/12 01/27/14
FDA-2013-P-0048James ReichmannReclassify Drug Ondansetron (Zofran)01/07/1307/03/13 
FDA-2013-P-0070Ikaria, Inc.Rescind 510(k) Clearance for GeNo, LLC 01/14/1307/10/13 
FDA-2013-P-0076DuVal & Associates; Minnesota Medical Device AllianceStay of Action in Process of Reviewing 510(k)'s 01/16/1307/03/1307/25/14
FDA-2013-P-0199Richard KarcichCitizen Petition Request to FDA to Issue New Regs or Amend Existing Regs Covering Measurement of Safety and Reliability of Software in Medical Devices02/15/13  
FDA-2013-P-0235Wess Eric SharpeRequest 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 I02/26/13  
FDA-2013-P-0667American Clinical Lab AssociationRegulating Laboratory Developed Tests (LDTs)06/04/1311/26/13 07/31/14
FDA-2013-P-0735Mario MoraisSupport Chronic Cerebrospinal Venous Insufficiency (CCSVI) as an MS Treatment06/11/13  
FDA-2013-P-0944Jeffrey G. Thomas on behalf of Marteen Moore515(g) Petition Regarding the Conditions of Premarket Approval of the DURASEAL® Spinal Sealant 08/01/13  
FDA-2013-P-0949Garrett 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 08/09/1302/05/14 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-0997Thomas J. QuinnRequesting 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-1080Garrett Skelly, Esq., for Reginald BurgessRequesting FDA to amend 21 CFR 820.198 to add a provision regarding Manufacturer Complaint Files 09/04/1302/24/1406/02/14
FDA-2013-P-1297Kevin BoultonIssue 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-1374Frederick 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 11/20/1303/07/14  
FDA-2013-P-1611Clarissa ClarkeAmend 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-0038Jennifer Butsch, Riverain TechnologiesRequest to Reclassify ClearRead+Detect, a CADe device, from Class III to Class II 12/18/1306/17/14 
FDA-2014-P-0111Ms. 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 II01/23/1407/07/14 
FDA-2014-P-0143Gail GudmundsenPersonal Sound Amplification Products 01/28/1407/14/14  
FDA-2014-P-0158H.Christopher Schweitzer, Ph.D., F-AAARefrain 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 01/30/1407/22/14  
FDA-2014-P-0159Mead 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 01/30/1407/22/14 
FDA-2014-P-0231Adaptive Engineering Inc.Exempt the Manually Operated Wheelchair Lift From the 510(K) Premarket Notification 02/24/14  
FDA-2014-P-0283Leroy L. HamiltonRevise Form FDA 3429 to Indicate the Appropriate Classificationof a Medical Device 03/06/14 05/16/14
FDA-2014-P-0290Leroy L. HamiltonDirect 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-0427Medicem TechnologyReclassify Dilapan 04/10/14  
FDA-2014-P-0445Robert Larry LytleRequests 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. 04/14/1405/30/14  
FDA-2014-P-0654Edwards Life-SciencesFDA grant a variance from specific quality system requirements for the delivery systems and accessories of the SAPIEN XT THV05/20/14  
FDA-2014-P-0802Moon T. KwonFDA 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 06/17/1407/22/14  
FDA-2014-P-0825OrthoFixRequesting 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 period06/19/1412/17/14 
FDA-2014-P-0831OrthoFixFDA 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 class06/20/1412/17/14 
FDA-2014-P-0919ShumaierFDA 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 07/01/1412/23/14 
FDA-2014-V-1503Timothy J. Connors, Integra LifeSciences CorporationApprove 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)10/02/1403/30/15 
FDA-2014-P-1673Tia GonnellaRequest 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 setting10/23/1412/22/14 
FDA-2015-P-0014Edward L. Boshnick, O.D.; Roger D. Davis, Ph.D.; Richard B. Smith, Ph.D.Request that the FDA add a black box warning concerning the high incidence of induced visual symptoms to the device labeling of all excimer lasers used in laser eye surgery presently on the market in the U.S.01/05/15  
FDA-2015-P-0051Christopher E. Bossi, Inrange Systems, Inc.Take action to protect patient safety by detaining the product manufactured or sold by; PharmRight Corporation under the product name "Livi"01/06/15 03/02/15
FDA-2015-P-0095Mark DuVal, DuVal and Assoc. (Leonhard Lang, GmbH)Request that the FDA grant an exemption from the medical device tracking requirements recently ordered01/09/15  
FDA-2015-P-0569Marcus 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” product01/24/15 03/26/15
FDA-2015-P-0703Sarah Salem-RobinsonIssue Ban on Laparascopic Power Morcellators03/05/15  
FDA-2015-P-1197Brian Orwat, Stryker MedicalRequest amendment to Regulation 21 CFR 890.3110 Electric Positioning Chair to Exempt Classification from Premarket Notification04/13/15  

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

Page Last Updated: 04/20/2015
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