Senator tells FDA to Seek Medical Device Industry's Expertise before Changing 510(k) Process
U.S. Senator Al Franken (D-MN) urged a top official at FDA to seek input from medical device manufacturers in Minnesota and across the country before changing the approval process for new products.
FDA has asked the Institute of Medicine (IOM) to review the current 510(k) process and specifically to consider several issues relating to the device review and approval process.
In a letter to Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health at FDA, Franken said the expertise and concerns of manufacturers too often have been ignored when changes are made to the 510(k) review process for new products.
He believe that the medical device industry contains a wealth of expertise that is too often neglected when considering changes to the device review process. I strongly encourage you to establish a clear process for soliciting and considering the suggestions and concerns of the medical device industry on any and all recommendations made by IOM before finalizing or implementing any changes to the process.
The Institute of Medicine is expected to issue its recommendations to FDA on changes to the 510(k) regulatory process.
New process would be too onerous and will hinder efforts to bring new life-saving devices to the market. Last FDA committed to releasing specific plans for changes to the process by the end of the 2010 and to seeking public comment before implementing those changes.
Franken had held a summit in Minnesota with leading Minnesota medical device manufacturers to hear their concerns regarding FDA's regulatory process. Minnesota's medical device community includes more than 400 companies that employ more than 30,000 people.
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