Twin Cities Business: Franken to FDA: Get Input Before Changing 510(k) Regs
Minnesota Senator Al Franken is asking the U.S. Food and Drug Administration (FDA) to consider the medical device industry's suggestions and concerns before making additional changes to the 510(k) device approval process that are now under consideration.
Franken on Tuesday sent a letter to Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, urging the agency to tap the medical device industry's expertise before moving forward with recommendations being considered.
Earlier this year, the FDA released a plan to update the 510(k) approval process—a 35-year-old system used to approve the majority of medical devices for market. That plan contains 25 actions that the agency intends to implement this year. A handful of those actions have already been put into practice, but most of them are scheduled to be implemented later this year.
© Al Franken - U.S. Senator, Minnesota, 2011. |
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