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, meanwhile, worry that some of the proposed changes would needlessly disrupt a process that's been in place for more than 30 years.

Franken said he plans to meet with FDA Commissioner Margaret Hamburg next month to share the industry's concerns.

"Minnesota is a global leader in medical device development," Franken said in a statement. "We are fortunate to be home to these companies that provide tens of thousands of high-quality jobs in our state. I am committed to bringing the concerns of Minnesota device companies to the FDA so that we can continue to foster medical innovation and protect patient safety."

Minnesota is home to more than 400 medical device companies employing more than 30,000 people.