| 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 |
|
11/3/2005 |
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
| 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 |
|
|
| 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 |
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