UPDATED Dec. 7, 2011 at 5:45 p.m. to add Brown quote
Sen. Scott Brown (R-Mass.) wants the FDA to make it easier for medical device makers to get new, less risky devices through the federal watchdog agency.
The measure, “A bill to amend section 513 of the Federal Food, Drug, and Cosmetic Act to expedite the process for requesting de novo classification of a device” (S-1943), co-sponsored by New Hampshire Republican Sen. Kelly Ayotte, would change the way companies apply for so-called “de novo” 510(k) clearances – in effect fast-tracking a program already meant to be the fast track. The 510(k) protocol is designed for devices that are advances on products the agency’s Center for Devices & Radiological Health has already cleared (“predicate” devices) that don’t need to go through a more rigorous review process.
In cases where the manufacturer believes there is no precedent, and the device poses only low or moderate safety risks, Brown’s bill would allow companies to request the de novo label from the agency without a 510(k) application as is currently required.
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“This legislation would cut red tape for innovators and allow new products to reach patients faster,” he told MassDevice in an email. “The United States leads the global medical device industry, and in order to stay on top and keep jobs in America, we have to make sure businesses can develop new, life-saving and life-improving technology by removing unnecessary regulations and increasing flexibility.”
Brown’s bill builds on legislation filed earlier this year in the U.S. House by Rep. Brian Bilbray (R-Calif.), according to FDA Law Blog. It’s been referred to the Senate Committee on Health, Education, Labor, and Pensions.
Both Brown and Ayotte have strong medical device clusters in their states; the Massachusetts med-tech sector is one of the three largest in the U.S., along with California and Minnesota.
Brown, elected to take the seat of the late Sen. Ted Kennedy (D-Mass.), made opposing the medical device tax a key plank in his 2010 campaign platform and has been a consistently vocal opponent since winning that race. He’s gearing up for a re-election campaign ahead of next year’s elections, facing the winner of the Massachusetts Democratic primary. That pack’s leader is Elizabeth Warren, President Barack Obama’s one-time pick to lead a new federal consumer protection agency.
The Warren campaign did not immediately respond for a request for comment.
