This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.
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.)