Program
510(k) Third PartyCDRH
FDA CDRH · 510(k) Third Party Review Program
Independent Third Party 510(k) Review.
GTPR is an FDA-recognized 3P510k Review Organization conducting primary reviews of eligible medical-device submissions. Reviews apply the same criteria FDA applies, within GTPR's recognized scope. FDA retains final authority for all 510(k) clearance decisions.
Recognized scope
Class I & IIRecognized product codes
Review role
Primary reviewIndependent evaluation
Recognizing authority
U.S. FDACDRH
Final authority
U.S. FDAAll clearance decisions
What is Third Party Review?
An FDA-recognized 3P510k Review Organization performs the primary technical and regulatory review of an eligible 510(k) submission, then forwards its assessment and recommendation to FDA through the Third Party pathway.
Within its recognized scope, GTPR evaluates the submission against the same criteria FDA applies — substantial equivalence, performance, labeling and applicable standards. FDA then conducts its own review of that documentation and issues the decision.
FDA retains final authority for all 510(k) clearance decisions.
Why the Third Party pathway exists
A factual overview. The pathway does not change the review criteria and does not alter FDA's role as the final decision-maker.
- 01A voluntary alternative pathway for eligible medical devices. About half of 510(k)s FDA receives are eligible.
- 02Independent primary review by an FDA-recognized organization, using the same criteria as FDA.
- 03Eligibility is defined by FDA, by device type and product code.
- 04The sole payment is between the submitter and the review organization; there is no FDA user fee under the program.
- 05A review may include early interaction with FDA on current standards and guidance for the device type.
- 06FDA remains the final clearance authority for every submission.
How it works
A summary of the review sequence. Each stage is detailed on the Review Process page.
- 01EligibilityProduct code & scope evaluation.
- 02IndependenceConflict-of-interest screening before acceptance.
- 03Engagement & authorizationReview Agreement and FDA authorization letter.
- 04Primary technical reviewSubstantial equivalence, performance, labeling, standards.
- 05Interactive reviewQuestions and deficiencies resolved through review.
- 06Review determinationGTPR completes its assessment and recommendation.
- 07FDA final reviewFDA remains the final authority for the decision.
Recognized Review Scope
GTPR reviews eligible Class I and Class II devices within its FDA-recognized product-code scope, organized by FDA device panel. Select a panel to view product codes, or verify the current recognized scope on FDA.gov.
Eligibility depends on FDA Third Party program eligibility and GTPR's current recognized scope. The authoritative, current record is published by FDA. Open Recognition & Scope · Verify on FDA.gov
Independence & governance
Our Review Unit operates strictly as an independent regulatory evaluator.
Conflict-of-interest screening is completed before any engagement is accepted. GTPR does not:
author or prepare submissions that it reviews.
advocate for sponsors before FDA.
guarantee clearance or a review timeline.
provide conflicted consulting on a submission under review.
Partners
Selected academic and ecosystem collaborations. Partnerships have no influence over eligibility determinations, reviewer assignment, review findings or regulatory recommendations.
Logo
IIT BombayAcademic & regulatory scienceLogo
HTIC — IIT MadrasHealthcare Technology Innovation CentreLogo
T-Hub, HyderabadMedTech ecosystemLogo
Global HealthXMedTech ecosystemDetermine whether your device is eligible for Third Party review.
Eligibility depends on FDA program eligibility and GTPR's recognized scope.