FDA Center for Devices and Radiological Health Releases New 510(k) Guidance Documents

| 28 December 2011 |  By 

The US Food and Drug Administration (FDA) released a bevy of new draft guidance documents on Tuesday for the 510(k) submission pathway. The documents include information regarding the Center for Devices and Radiological Health (CDRH) appeals process,  evaluating substantial equivalence in premarket notifications, CDRH's plan of action for 510(k) and science, an updated schedule of planned and accomplished CDRH regulatory science activities, and standard operating procedures for staff changes occurring during a premarket device submission.

The documents were accompanied by updated training materials on the CDRH website and a blog post by CDRH director Jeffery Shuren,  M.D., J.D..  In the posting, Shuren makes frequent reference to criticisms leveled by industry and noted that CDRH has taken several efforts to accommodate those criticisms in the new draft guidances.  "[The documents make] the existing regulatory framework more transparent and predictable by clearly articulating many of the longstanding practices and policies underlying the 510(k) program," said Shuren.

According to the draft 510(k) guidance, "This draft guidance is not intended to implement significant policy changes to the current 510(k) review process. Rather, the intent of this guidance is to enhance the predictability, consistency, and transparency of the 510(k) program by describing in greater detail the regulatory framework, policies, and practices underlying FDA's 510(k) review. This guidance also updates FDA's policies with respect to the Special 510(k) program."

The Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications is open for comment for 120 days.

In the case of SOP: Management of Review Staff Changes During the Review of a Premarket Submission, the standard operating procedure is the first update that particular SOP since 1990, and attempts to provide a stable and predictable platform for staff turnover and the transition of responsibilities. 

The Draft Guidance for Industry and Food and Drug Administration Staff - CDRH Appeals Process similarly aims to provide clarity for industry who want to appeal an industry decision and FDA staff who are charged with processing those appeals.  The Draft Guidance replaces several earlier guidance documents, and lays out several processes, paths and expectations for companies wishing to appeal a CDRH decision.


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