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FDA Medical Device Safety

 

Letters

Feb. 15, 2008 Letter to GAO Comptroller General Walker requesting information about the Agency's oversight study of the FDA
Jan. 18, 2008 Letter to McMoran, O'Connor & Bramley, P.C. in regard to decisions made by FDA officials regarding the CYPHER Coronary Stent
Dec. 13, 2007 Letter to HHS Secretary Leavitt in regard to the recently signed Memorandum of Agreements between China and the United States
Dec. 13, 2007 Letter to the Biomedical Research Institute of America and Texas Applied Biomedical Services in regard to the ability of Institutional Review Boards to protect human subjects in biomedical research
Nov. 26, 2007

Letter to Government Accountability Office Comptroller General Walker in regard to the FDA's ability to ensure the safety of medical devices

Dec. 4, 2007 response »

Nov. 21, 2007 Letter to FDA Commissioner von Eschenbach in regard to the ability of Institutional Review Boards to protect human subjects in biomedical research
Aug. 13, 2007

Letter to FDA Commissioner von Eschenbach in regard to the circumstances surrounding an FDA recall letter to to Cordis Corporation about the CYPHER Coronary Stent

May 28, 2008 response »
Jan. 25, 2008 response »

Nov. 27, 2007 response »

Sept. 27, 2007 response »
Sept. 25, 2007 response »
Aug. 16, 2007 response »

Aug. 13, 2007

Letter to Johnson & Johnson CEO Welden in regard to the circumstances surrounding an FDA recall letter to to Cordis Corporation about the CYPHER Coronary Stent

Sept. 4, 2007 response »

 

News Releases

"Dingell, Stupak Comment on FDA Plan for Overseas Inspections" -- January 25, 2008

"Dingell, Stupak Investigating Institutional Review Boards, Questionable Medical Devices" -- December 13, 2007

"FCC Chairman Martin Responds to Letter from Chairman Dingell on Commission Procedures" -- December 11, 2007