Massachusetts Device Makers Urge FDA To Abandon Controversial 510(k) Reform Proposals

Massachusetts device makers are pressing FDA to abandon the controversial 510(k) reform recommendations currently awaiting input from the Institute of Medicine.

As part of its review of the 510(k) pre-market clearance program, IOM has been asked to consider seven particularly divisive FDA-generated proposals, including whether the agency should split class II devices into two subcategories, with one requiring a greater degree of oversight. (See “ FDA 510(k) Reform Plan Yields Mixed Readings ” – “The Gray Sheet” Jan. 24, 2011.)

“We’d like to see the provisions … dropped,” Tom Sommer, president of the Massachusetts Medical Device Industry Council (MassMedic), told “The Gray Sheet.” “We would prefer that the agency not implement some of these most controversial recommendations.”

Industry representatives delivered the message during a July 11 closed-door meeting in Boston attended by FDA Commissioner Margaret Hamburg, CDRH Director Jeffrey Shuren and more than 50 device executives. The meeting was arranged by Massachusetts Democratic Senator John Kerry.

“Over the past several years, from the perspective of most in this industry, we have seen troubling signs that we believe will jeopardize our position as the world’s foremost medical device cluster,” Sommer told the FDA officials.

IOM’s 510(k) assessment is expected out in late July.

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