FDA Publishes De Novo Classification Final Rule with Few Changes from the Proposed Rule
FDA Law
OCTOBER 25, 2021
Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. Yet, all this time, this process lacked implementing regulations governing the process and the criteria for approval. The regulatory uncertainty has ill?befitted Part 807, Subpart E). The new rule will be codified in 21 C.F.R.
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