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

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

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

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. #

By | 2011-08-11T14:28:54+00:00 August 11th, 2011|Media Reports|0 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.

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