510(k) Reform: Minnesota Congressional Delegation Lines up in Opposition, Mass Device, August 3, 2011Aug 11th, 2011 | By Jane Akre | 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.
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”.
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. #