FDA seeks more industry opinion about Device approval process, Star Tribune, August 2, 2011

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FDA seeks more industry opinion about Device approval process, Star Tribune, August 2, 2011

The medical device industry is very concerned following an Institute of Medicine report that the fast-track system for getting devices on the market should be scrapped, reports the Twin Cities Star-Tribune.

Dr. Jeffrey Shuren, who heads the FDA’s device division flew to attend a town hall meeting  with executives to assure them it might not be necessary to start all over with 510 (k).

The Food and Drug Administration is looking for more input after receiving a recommendation last week that it scrap the controversial pathway for medical device approvals (510(k)) and design a new process.

FDA officials told device industry executives at a town hall meeting in St. Paul on Tuesday that they remain open to ideas to improve the 510(k) method of device reviews, which generally doesn’t require clinical trials. The agency is gathering public comment, a process that should be complete by October.

“Let’s have that discussion,” said Dr. Jeffrey Shuren, head of the FDA’s device division. “If there are any recommendations that make sense, we’ll consider them.”

Read the rest of the story here. 

 

By | 2011-08-13T15:49:22+00:00 August 13th, 2011|FDA News, 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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