Is My Device Eligible for FDA Third Party Review?
Request an eligibility review with TPRG today!
FDA Eligibility
Is My Device Eligible for FDA Third Party Review?
Most FDA Third Party Review submissions involve eligible Class II medical devices with established product codes and legally marketed predicate devices. TPRG can help determine whether your device qualifies for the FDA Third Party Review Program before you begin the submission process.
What Devices Are Eligible?
Eligible devices generally:
✅ Are Class II medical devices
✅ Have an FDA-recognized product code
✅ Have an appropriate predicate device
✅ Are included in the FDA Third Party Review Program
What Devices Are Not Eligible?
Common examples include:
❌ PMA devices
❌ De Novo requests
❌ Certain high-risk Class II devices excluded by FDA
❌ Products not included in the FDA Third Party Review Program
Can Special 510(k)s Be Reviewed Through TPRG?
Some Special 510(k) submissions may qualify depending on the device type and FDA eligibility criteria. TPRG can review your situation and determine the most appropriate pathway.
Unsure About Eligibility?
Before investing time in a full submission, manufacturers can request an eligibility review from TPRG.
Our team can assess:
- Device classification
- Product code
- Predicate device strategy
- Third Party Review eligibility