THIRD-PARTY PILOT TO INCLUDE 200-300 DEVICE TYPES COVERING 1,500 510(k)s PER YEAR, FDAer SAYS; PROGRAM WILL INVOLVE ABOUT 10 OUTSIDE REVIEW GROUPS
This article was originally published in The Gray Sheet
Executive Summary
A Federal Register notice unveiling FDA's pilot program for third-party review of 510(k)s is slated for publication in about two weeks. The notice is expected to give FDA the authority to sign off on premarket notifications reviewed by outside groups beginning 120 days after publication, meaning the agency theoretically could start accepting 510(k)s reviewed by outside groups as early as July, Eric Rechen, a policy analyst in FDA's Office of Device Evaluation, said Feb. 26 at the ACIL Federal Issues Forum in Washington, D.C.
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