The Hill: Franken seeks industry input on medical device approval process

Sen. Al Franken (D-Minn.) is holding a summit Friday afternoon with his state's medical device manufacturers to get their input on proposed changes to the way federal regulators approve new products.

Earlier this month, the Food and Drug Administration (FDA) announced more than 70 proposed changes to its 510(k) program, which allows expedited review of low- and moderate-risk medical devices. Some consumer advocates and insurers argue that the current standards are too lax; device makers...

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Published on August 20, 2010 08:19
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