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Glossary

Pre-Sub Meeting

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FDA Pre-Sub meetings are available for manufacturers to obtain regulatory feedback on various medical device applications in the US in the frame of clinical studies (i.e. Investigational Device Exemptions IDE), or premarket regulatory submissions (i.e. 510(k), De Novo, PMA etc.). The FDA Pre-Sub program can prove especially valuable for innovative medical devices for which predicate devices are difficult to identify.

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