Regulatory resource library.
Authoritative FDA references for the Third Party Review Program, alongside GTPR's own program documentation.
Regulatory resource library
Authoritative FDA sources for the Third Party Review Program, plus GTPR's own program pages. Links marked open on FDA.gov.
510(k) Third Party Review Program — FDA overview
510(k) Third Party Review Program guidance (FDA)
Current list of FDA-recognized 3P510k organizations
List of devices eligible for Third Party review
FDA product classification database
FDA 510(k) database (cleared submissions)
510(k) Third Party performance metrics (FDA)
GTPR recognition & recognized scope
GTPR review process
GTPR independence & governance
Check device eligibility
Frequently asked questions
Does GTPR grant FDA clearance?
No. GTPR conducts the primary review of eligible 510(k) submissions within its recognized scope and forwards its assessment and recommendation to FDA. FDA retains final authority for all 510(k) clearance decisions.
Is my device eligible for the Third Party pathway?
Eligibility depends on FDA program eligibility, product code, classification and GTPR's recognized scope. Use the eligibility form for a determination.
Does a Third Party review guarantee a faster or successful outcome?
No. GTPR does not guarantee clearance or a review timeline. Each submission is evaluated on its own record.
Can GTPR also prepare my submission?
No. GTPR does not author or prepare submissions that it reviews, and does not provide conflicted consulting on a submission under review.