The Hill: Franken seeks industry input on medical device approval process
Posted in News Clips on August 20th, 2010Sen. 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, meanwhile, worry that some of the proposed changes would needlessly disrupt a process that’s been in place for more than 30 years.




