510(k) Reform: Minnesota Congressional Delegation Lines up in Opposition, Mass Device, August 3, 2011

Aug 11th, 2011 | By | Category: Media Reports

Sens Amy Kloubechar (D-Minn.), Al Franken (D-Minn.) and Rep. Erik Paulsen (R-Minn) reject calls by the Institute of Medicine to kill the 510(k) program that allows medical devices on the market without premarket approval.

Sen. Al Franken (D-MN)

In a joint statement the lawmakers rejected a July 2011 Institute of Medicine findings that the FDA should scrap the 510(k) approval process for medical devices because it is “fatally flawed”.

See the article in Mass Device.  Here is a news release concerning the IOM report.

Sen. Franken, once known for wearing a satellite dish on his head as a comedic news gatherer on Saturday Night Live, now represents Minnesota, a worldwide mecca for the medical device industry.  According to the University of Minnesota the medical devices industry employs tens of thousands of people and has more than 500 FDA-registered medical device companies.

Sen. Franken toured UM in February and met with university research and device company reps to get a briefing. #

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.