Sen. Franken to Shuren: Get industry input before changing 510(k) system

June 23, 2011 by MedCity News

Minnesota Sen. Al Franken (D) is urging the U.S. Food & Drug Administration to include the perspective of medical device manufacturers in his state and around the country before changes are made to the 510(k) approval process.

Franken's office issued a press release Thursday that said he sent a letter to Dr. Jeffrey Shuren, director of the Center for Devices & Radiological Health at the FDA, to express his concern that the industry's voice is not being heard in discussions to overhaul the 510(k) system.

Challengers argue that the 510(k) review process has been compromised. The FDA is reviewing the system and has asked the Institute of Medicine to provide recommendations.

"I understand that the 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," the letter from Franken read. "I 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 the IOM before finalizing or implementing any changes to the process."

News Well, 510(k) reforms, Food & Drug Administration (FDA)

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