FDA device approval: Too fast or too slow?

FDA device director Jeffrey Shuren and representatives from the medical device industry testified before the House Energy and Commerce health subcommittee last week about the current state of the medical device approvals in the U.S. The agency is currently overhauling the 35-year-old device approval process.

Devicemakers complain that the FDA is too slow with approvals, noting that it generally takes two years longer to get a device approved in the U.S. than it does in Europe. They also complain that the FDA has become unpredictable with what data it wants to see in device applications. The uncertainty companies face has forced many to launch their products overseas in order to stay afloat while they wait FDA approval. "Investment is drying up, companies are moving overseas or closing their doors, and U.S. patients are being denied timely access to safe and effective new medical products," said Josh Makower, a medical device inventor and consulting professor at Stanford University, according to the Washington Post.

Shuren, for his part, acknowledged that the FDA asks for efficacy data in addition to safety data: something the EU doesn't require. But he blamed the industry for the declining number of approvals, noting that companies often submit applications missing key data. Poor application quality has contributed to the slower approval process. "We're stepping up to the plate to do our part to get this right. But if it's going to work, we need industry to do their part," Shuren told members of the subcommittee.

A third group--patient-safety advocates--contend that FDA approval is too fast. Cleveland Clinic cardiologist Steve Nissen says the agency is clearing too many devices through the 510(k) approval process, leading to more recalls of unsafe devices.

FDA leadership has the unenviable task of sifting through all the various viewpoints as it revamps the device approval system.

- here's the Washington Post article

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