Do you know the material and format specifications for Non-clinical Bench Performance Testing Premarket Submissions?
The latest FDA guidance specifies the relevant information to be included in a premarket submission, summaries, study protocols and full test report for non-clinical bench testing. Such submissions include premarket approvals (PMA), humanitarian exemption system (HDE) applications, premarket notification (510(k)) submissions, IDE applications, and De Novo applications. This advice ensures that you give the right information so that delays in your review process are avoided.
Download the directions here.