Device Review Process
More Information on the Device Review Process
- Letter to Congress Regarding Legislation to Reauthorize PDUFA and MDUFA, April 25, 2022
- Comments Submitted to the FDA Regarding Reauthorization of the Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027 (MDUFA V), April 21, 2022
- Testimony at the FDA’s Public Meeting Regarding Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027, April 19, 2022
- Letter to Congress Regarding Legislation to Reauthorize the Medical Device User Fee Amendments, March 29, 2022
- Letter to Congress Calling for Amendments to H.R. 6000, the Cures 2.0 Act, February 24, 2022
- Testimony Before the FDA’s Neurological Devices Advisory Committee Meeting Regarding BrainGate LTD’s Ischemic Stroke System, December 10, 2021
- Letter to the FDA Urging the Agency Not to Grant 510(k) Premarket Clearance for the TriGUARD 3 Cerebral Embolic Protection Device, August 17, 2021
- Presentation at the FDA’s Stakeholder Meeting on the Reauthorization of MDUFA, June 9, 2021
- Presentation at the FDA’s Public Kickoff Meeting on the Reauthorization of MDUFA, October 27, 2020
- Letter to the FDA Criticizing the Agency’s Response to Public Citizen’s Report on Implanted Spinal Cord Stimulators for Pain Relief, July 29, 2020
- Report: Implanted Spinal Cord Stimulators for Pain Relief – Illustrating the FDA’s Dangerously Lax Oversight of High-Risk Implantable Medical Devices, June 10, 2020
- Public Citizen Opposes Reclassification of Extracorporeal Membrane Oxygenation (ECMO) Devices, September 12, 2013
- Public Citizen comments on regulatory classification of automated external defibrillator (AED) devices, June 24, 2013
- Comments on Sorbent Hemoperfusion, Cranial Electrotherapy Stimulators, and Transilluminators for Breast Evaluation, May 6, 2013
- Comments Submitted to the FDA Regarding Extracorporeal Membrane Oxygenation (ECMO) Devices, April 8, 2013
- Comments Submitted to the FDA Regarding Automated External Cardiac Compressor Devices, April 8, 2013
- Letter to FDA on IABP Regulatory Classification, February 13, 2013
- Comments on FDA Guidance on Substantial Equivalence, April 26, 2012
- Letter to the FDA Opposing Reclassification of Cranial Electrotherapy Stimulator Devices, February 28, 2012
- Substantially Unsafe: Medical Devices Pose Great Threat to Patients; Safeguards Must be Strengthened, Not Weakened, February 15, 2012
- Comment on External Pacemaker Reclassification, January 17, 2012
- Comments Regarding the IOM’s Report, Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years, September 2, 2011
- Press Release: Public Citizen Applauds IOM’s Findings and Recommendations on 510(k) Medical Device Clearance Process, July 29, 2011
- Comments on FDA Medical Device Innovation Initiative, April 7, 2011
- Testimony on Classification of Automatic External Defibrillators, January 25, 2011
- Statement: FDA Dodges Responsibility Regarding Medical Device Approval, Defers to IOM, January 19, 2011
- Comments on FDA 510(k) Medical Devices Working Group Preliminary Report and Recommendations, October 4, 2010
- Article in PLoS Medicine on Breakdown of U.S. Device Review Process, July 2010
- Congressional Testimony Encouraging a More Rigorous Approval Process for Medical Devices, June 18, 2009
- Statement: GAO Report Documents Lax Device Approval Standards at FDA, January 15, 2009
- Letter in New York Times Criticizing Weaknesses in FDA Oversight of Medical Devices, October 28, 2008
- Congressional Testimony on Development of Pediatric Therapies, May 22, 2007
- Letter Asking FDA to Stop Companies from Promoting Laser Therapy for Smoking Cessation, June 22, 2006
- ECRI v. Guidant (Right to publish device prices), May 6, 2006
- Letter Requesting New Device Standards, September 14, 2005