CDRH's Shuren: FDA's 510(k) findings due soon

June 22, 2010 by MassDevice staff

Dr. Jeffrey Shuren, head of the Center for Devices & Radiological Health, tells a Woburn, Mass., town hall meeting that a report on the Food & Drug Administration's internal review of the 510(k) process is due within the next several weeks.

CDRH's Shuren: FDA's 510(k) findings due soon

Dr. Jeffrey Shuren, head of the Food & Drug Administration's medical device oversight arm, told a Massachusetts audience that results from the agency's internal, soup-to-nuts review of its 510(k) clearance program are due out in a few weeks.

At the second in a series of "town hall" meetings in Woburn, Mass., the Center for Devices & Radiological Health's leader said the federal watchdog would seek public comment on the report before making any changes to the program.

Shuren told MassDevice that the agency still hasn't decided exactly what changes are in store for the 510(k) process.

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