510(k) reform: IOM finally asks for medical device representation

April 1, 2011 by MassDevice staff

The Institute of Medicine is done with its internal review of the FDA's 510(k) medical device clearance program and is looking for input from industry for a peer review of its findings.

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The Institute of Medicine is done with its review of the FDA's 510(k) clearance protocol and wants to hear from the medical device industry about its findings.

Adding some med-tech voices to the panel could help quell persistent complaints that the medical device industry has been woefully under-represented in the FDA's 510(k) reform process. The IOM's independent review is part of the Food & Drug Administration's push to revamp the protocol by which a vast majority of medical devices are cleared for market in the U.S.

Dale Wahlstrom, head of LifeScience Alley/BioBusiness Alliance, an industry council representing the Minnesota med-tech community, told MassDevice that he was contacted by representatives of the IOM to suggest med-tech professionals who might help vet the report.

The email exchange was prompted by Sen. Al Franken (D-Minn.), Wahltstrom told us, who intervened on behalf of the industry to push for more representation from the private sector. The IOM in turn contacted Wahlstrom, who provided the institute with a list of names. He has not heard if any of the people he suggested were contacted, nor would he tell us who he recommended. Wahlstrom is a Medtronic Inc. (NYSE:MDT) veteran.

For a review board that could have wide repercussions for the device industry, the IOM panel is singularly lacking in representatives from the private sector. The only two business representatives on the board come from the health insurance industry, according to a report in the Minneapolis Star Tribune Minneapolis Star Tribune.

"How do you assemble a group of experts to make recommendations about a program they have very little direct experience with?" Mark Leahey, president of the Medical Device Manufacturers Assn., told MassDevice recently. "You need to expand [the panel] to include physician inventors and entrepreneurs, VCs, patients, so you have all the perspectives. Absent the inclusion of these additional individuals, any recommendations you put forth won't be credible."

Leahey added that the limited interactions the industry has had with the IOM have amounted to "token opportunities to provide input."

"I would argue IOM recommendations shouldn't have any bearing, because of a lack of expertise on the committee," he told us.