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FDA Details Time Clock Strategies for PMAs, 510(k)s in Draft Guidance

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The FDA last week released updated guidance describing how it intends to comply with submission review timelines set during user fee negotiations earlier this year. The documents — on PMAs and 510(k)s — revise guidances from 2008 and 2004, respectively, to explain how the agency will use the actual-time “review clock” schedule established in the FDA Safety & Innovation Act, as well as how actions submitters take might affect the timeline.
Devices & Diagnostics Letter