Manufacturers may need to supply additional data to FDA for a 510(k) clearance or PMA approval if their device contains novel materials, CDRH toxicologist Ron Brown told participants March 11 at a joint Association for the Advancement of Medical Instrumentation/FDA meeting in Herndon, Va.
Brown, of CDRH’s Division of Biology, Office of Science and Engineering Labs, expects sponsors of 510(K)s and PMAs to follow...
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