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What are submission deficiencies due to biocompatibility and how do medical device companies overcome them in trials, studies, and regulatory post-market surveillance?In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Chris Parker, Associate Department Head of In-Vivo Biocompatibility at Toxikon Corporation on how to overcome and prevent those submission deficiencies.Some of the highlights of this episode include:When a manufacturer puts their package together for a submission to the FDA, if it is not approved, then the FDA issues a deficiency or request for additional information due to a question or issue with some part of the submission.If a deficiency is issued, the FDA allows the manufacturer to handle it in one of two ways—either correct it through a memo/risk assessment or retest.It is better to be proactive rather than reactive when addressing a deficiency. A little bit of time upfront with the FDA will save a lot of time on the backend.Competition: When most medical device