FDA Hopes To Finalize Most 510(k) Reform Guidances In 2012

Article preview from "The Gray Sheet"- November 7, 2011

FDA says it aims to finalize as many 510(k) reform-related guidance documents as possible in 2012 to help clarify regulatory requirements for medical device makers. It’s no secret that draft guidance documents often languish at FDA – sometimes for years – but the agency vows that these high-priority documents will not suffer a similar fate.

 

FDA Hopes To Finalize Most 510(k) Reform Guidances In 2012

Article preview from "The Gray Sheet"- November 7, 2011

“We don’t want guidances out in draft form for years on end because we do want to bring some closure so companies will know what the expectations are and not have a moving goal post,” Joni Foy, acting deputy director for science and regulatory policy at FDA’s device center, said Oct. 28 at the IN3 Summit, hosted by Elsevier Business Intelligence, publisher of “The Gray Sheet.”

FDA kicked off its 510(k) reform effort this year, issuing four draft guidance documents, establishing four new standard operating procedures and launching a new reviewer training program, among other initiatives.

“This period of time seems to be probably one of the most intense in terms of just output,” Elaine Tseng, an attorney with King & Spalding’s FDA and Life Sciences practice, said at the IN3 meeting in San Francisco.

And before year end, the agency hopes to issue seven more draft guidances, additional SOPs, and proposed rules on unique device identification, device labeling and 510(k) transfers of ownership.

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