FDA Details Time Clock Strategies for PMAs, 510(k)s in Draft Guidance

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