An independent, FDA-recognized 3P510k Review Organization under the U.S. FDA CDRH 510(k) Third Party Review Program.
Check Eligibility

Determine whether your device can be reviewed through the Third Party pathway.

Eligibility depends on FDA Third Party program eligibility, product code, device classification, GTPR's recognized scope and conflict-of-interest clearance.

This first-stage form collects only the information needed to assess eligibility. Please do not upload or include confidential submission documents. If an engagement is accepted, documents are exchanged through a secure sponsor intake process — never an ordinary web form. Submitting this form does not create an engagement or constitute an FDA submission. FDA retains final authority for all 510(k) clearance decisions.

What determines eligibility

Eligibility for the FDA Third Party 510(k) pathway depends on several factors, each assessed before an engagement is accepted:

  • FDA program eligibilityThe device type must be eligible under the program.
  • Product code & classificationDetermined by the device's FDA product code and class.
  • GTPR recognized scopeThe code must fall within GTPR's current recognized scope.
  • Conflict-of-interest clearanceIndependence must be confirmed for the engagement.
Browse recognized scope