Tag: Premarket Submissions

Do you know the content and format requirements for submitting Premarket Submissions for Non-Clinical Bench Performance Testing?

Recent FDA guidance describes the relevant information that should be included in test report summaries, test protocols and complete test reports for non-clinical bench performance testing provided in a premarket submission. These submissions include: premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications, and De Novo requests.
This guidance will ensure you provide the correct information to avoid delays in your submission review process.

Download the guidance here.