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.”
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