Novel Materials In Devices May Require Additional Biocompatibility Testing

17 Mar 2014

FDA reviewers ask manufacturers to put novel materials in devices through additional testing beyond what is described in existing guidance documents.

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...