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Focus on Regulation

Tag Archives: CDRH

FDA Issues Draft Guidance on Co-Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

On September 21, 2016, FDA issued a draft guidance titled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices – Draft Guidance for Industry and Food and Drug Administration Staff.”  This draft guidance describes FDA’s suggested steps for seeking approval of an antimicrobial drug and any related antimicrobial susceptibility test (AST) devices in order

CDRH Goes Back to the Drawing Board on Proposed Revisions to 510(k) Modification Guidance

Based on stakeholder comments raising serious concerns about a significant increase in the number of new 510(k) submissions that would be required for minor changes to 510(k)-cleared devices, CDRH Director, Jeffrey Shuren, recently signaled that the medical device center is revisiting its 27 July 2011 proposed draft guidance, 510(k) Modifications:  Deciding When to Submit a