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Food & Drug Administration (FDA)
Related Resources (government documents and letters)
POGO Files
POGO's letter to Commissioner Hamburg regarding medical devices
October 14, 2009
CDRH Director Offers Resignation
August 11, 2009
FDA's Risky Gamble with the Safety of Medical Devices
February 18, 2009
The FDA's Deadly Gamble with the Safety of Medical Devices The Food and Drug Administration's Center for Devices and Radiological Health (CDRH) oversees the safety of medical devices. Internal documents obtained by POGO reveal a decision made by senior CDRH officials that could put patients' lives at risk. Since 2006, the FDA is not ensuring that medical devices such as cardiac defibrillators, pacemakers, replacement heart valves, and coronary artery stents are being tested according to good laboratory practices.
February 18, 2009
Correspondence between POGO and the Center for Devices and Radiological Health (CDRH) of the FDA
October 9, 2008
Related Resources
Letter from FDA Commissioner Hamburg to POGO regarding medical devices
Margaret A. Hamburg, M.D., Commissioner for Food and Drug Administration, Department Of Health & Human Services
September 25, 2009
Response Letter from Casper Uldriks, DHHS
Casper E. Uldriks, Associate Director, FDA, Regulatory Guidance and Government Affairs, Center for Devices and Radiological Health, Department of Health & Human Services
May 27, 2008
POGO in the News
2009: Turmoil Erupts at CDRH, By James G. Dickinson, Medical Device Link.Com, December 1, 2009
Daniel Schultz Resigns Amid CDRH Controversies, By James G. Dickinson, Medical Device Link.com, October 1, 2009
Firm Aggressively Campaigned for Device, By Dan Eggen and Lyndsey Layton, The Washington Post, September 26, 2009
Fast-Tracked Medical Device Review Will Take Two Years, By Jane Akre, InjuryBoard.com, September 25, 2009
U.S. FDA seeks outside review of device approvals, By Susan Heavey, Reuters, September 23, 2009
FDA changes afoot?, By Shawn Rhea, Modern Healthcare (by subscription only), August 17, 2009
U.S. FDA device chief leaves, changes seen, By Susan Heavey, Reuters, August 11, 2009
Safety concerns over life sustaining medical devices, , WQAD.com, July 8, 2009
FDA Head to Look at Medical Device Safety, , NEWSInferno.com, June 17, 2009
Report: FDA Dropped Early Medical Device Lab Inspections, , Medical Report Outsourcing (Blog), June 8, 2009
Watchdog Group Wants Probe in Syringe Case, By Christina Jewett, ProPublica & Chris Walker, Chicago Tribune, June 8, 2009
A Covertly Drops Inspection of Medical Device Labs, By David Gutierrez, Natural News, May 30, 2009
HealthFirst-Dangerous Devices, By Leslie Toldo, ABC12.com, May 20, 2009
Health First-Dangerous Devices, By Leslie Toldo, Health and Medical News from ABC12.com, May 20, 2009
Is more regulation the answer?, By Rob Waters, Raleigh News Observer, March 1, 2009
As the federal stimulus billions begin to flow, oversight essential, , Stockton Record, On-line, February 27, 2009
FDA ignored debris in syringes, By Sarah Avery & Sabina Vollmer, Raleigh News & Observer, February 25, 2009
Feds searching for CEO in case of tainted syringes, By Mike Baker, Associated Press, February 24, 2009
Lack of GLP Inspections Leads to Hasty Device Approvals, By Renee Frojo, Device & Diagnostic Letter, February 23, 2009
FDA All But Stopped Inspecting Labs That Test Medical Devices, , FDA Week, February 20, 2009
Report: FDA scaled back enforcement at labs, By Ricardo Alonso-Zaldivar, Associated Press; ABC News , February 18, 2009
Watchdog Says FDA Abandoned Safety Measure, By Lisa LaMotta, Forbes Online, February 18, 2009
Internal FDA Documents Reveal Agency Stopped Enforcing Standards, By Daphne Eviatar, Washington Independent, February 18, 2009
FDA Not Enforcing Medical Device Testing Standards, By Jared Favole, DowJones Newswires, February 18, 2009
Activists decry paucity of US FDA device checks, By Susan Heavey, Reuters, February 18, 2009
Watchdog Blasts FDA On Loose Test Compliance Policy, By Anna Edney, Congress Daily, February 18, 2009
Watchdog: FDA decision under Bush put patients in danger, By Greg Gordon, McClatchy Newspapers, February 18, 2009
