Stuart Smalley to Med Device Community “You’re Good Enough, You’re Smart Enough…”

Stuart Smalley to Med Device Community “You’re Good Enough, You’re Smart Enough…”

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Sen. Franken to Top FDA Official: Seek Medical Device Community’s Expertise Before Changing Approval Process for New Products

WASHINGTON, D.C. [06/23/11] – U.S. Sen. Al Franken (D-Minn.) on Tuesday urged a top official at the Food and Drug Administration (FDA) to seek input from medical device manufacturers in Minnesota and across the country before changing the approval process for new products.

Sen. Franken, in a letter to Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health at the FDA, said the expertise and concerns of manufacturers too often have been ignored when changes are made to the review process for new products, known as the 510(k) process.

“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,” Sen. Franken wrote to Director Shuren in a letter. “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.”

The Institute of Medicine (IOM) is expected to issue its recommendations to the FDA on changes to the 510(k) regulatory process.

Sen. Franken has heard from Minnesota companies that the process is too onerous and hinders efforts to bring new life-saving devices to the market. Last year, he met with FDA Commissioner Margaret Hamburg, who 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. Prior to the meeting with Commissioner Hamburg, Sen. Franken held a summit in Minnesota with leading Minnesota medical device manufacturers to hear their concerns regarding the FDA’s regulatory process.  Minnesota’s medical device community includes more than 400 companies that employ more than 30,000 people. Sen. Franken sits on the Senate Health, Education, Labor, and Pensions Committee, which oversees the FDA.

The full text of the letter is available here.


 

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