FDA’s Third Party Review Program is Ready for the Next Pandemic, not the LDT Final Rule
FDA Law Blog
DECEMBER 16, 2024
By Adrienne R. Lenz, Principal Medical Device Regulation Expert FDA recently released 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review which finalizes the draft guidance of the same title issued in December 2023. We previously discussed the Third Party Review Program in a blog post last year when FDA mentioned its expansion as part of its plan to address the resource gap for review of laboratory developed tests (LDTs) under the LDT final rule.
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