Established in 1995, the pre-IDE program has been a successful resource for both medical device applicants and FDA and has become the most commonly used mechanism for requesting FDA’s feedback prior to a premarket device submission.

Intentially, this program was designed to provide applicants a tool to obtain FDA feedback on planed IDE applications prior to their submission. This new guidance ioncludes a broader scope of the program.

 

See --> Requests for Feedback on Medical Device Submissions. The Pre-Submission Program and Meetings with FDA