Pre-Submission Meeting
Pre-Submission Meeting
A FDA Pre-Submission program is a meeting with the FDA where they provide you with feedback before submitting your formal medical device application.
It is voluntary, not mandatory, and is a way for you to fix gaps in your application before submitting your final version.
Feedback can be requested in various forms (written response, teleconference or face to face meeting) and cover numerous types of Medical Device submissions (510 (k), PMA, De Novo Petitions, IDE, CLIA, etc.)
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