The FDA 510(k) Third Party Review Program.
How the program is structured, who does what, and where GTPR's recognized primary review fits within FDA's final decision-making authority.
What is the Third Party Review Program?
The FDA 510(k) Third Party Review Program is a voluntary alternative review process in which FDA-recognized organizations conduct the primary review of eligible lower-to-moderate risk devices. It is authorized under section 523 of the Federal Food, Drug, and Cosmetic Act and administered by CDRH.
The program lets FDA focus resources on higher-risk devices while maintaining oversight of the review of eligible lower-risk devices. Review organizations apply the same criteria FDA applies.
Roles within the program
Role of the Review Organization
Within its recognized scope, GTPR performs the primary technical and regulatory review — substantial equivalence, performance, labeling and applicable standards — and forwards its assessment and recommendation to FDA.
Role of the Sponsor
The sponsor provides a complete, accurate submission, including the authorization that permits the review organization to forward the 510(k) to FDA and to discuss it with FDA, and responds to review questions.
Role of FDA
FDA remains the final regulatory authority. By statute, FDA issues its final decision within 30 days of receiving a Third Party's recommendation. That decision — clearance or otherwise — rests solely with FDA; a recommendation is not a clearance. FDA retains final authority for all 510(k) clearance decisions.
Eligible submissions
Eligibility is defined by FDA by device type and product code, and is further limited by GTPR's recognized scope. Devices involving novel intended uses or otherwise excluded by FDA are not eligible.
Third Party vs. direct FDA pathway
A neutral, factual comparison. Neither pathway alters the review criteria or guarantees a clearance outcome or timeline.
| Aspect | Direct FDA 510(k) | Third Party 510(k) |
|---|---|---|
| Primary reviewer | FDA review staff. | FDA-recognized 3P510k Review Organization, within recognized scope. |
| Eligibility | Broad; most 510(k) device types. | Limited to FDA-eligible device types and product codes. |
| Review criteria | FDA criteria. | The same criteria FDA applies. |
| Final decision | FDA. | FDA issues the final decision after receiving the recommendation. |
| User fee | Standard FDA 510(k) user fee applies. | No FDA user fee under the program; the sole payment is to the review organization. |
| Review interaction | With FDA. | With the review organization during primary review; FDA at final review. |
See what happens once a sponsor approaches GTPR.
A full, stage-by-stage account of the review process.