FDA recognition & recognized scope.

GTPR's recognition under the FDA CDRH 510(k) Third Party Review Program, and the recognized product codes it may review — verifiable directly on FDA.gov.

FDA recognition

Global Third Party Review Private Limited is recognized by the U.S. FDA (CDRH) as a 3P510k Review Organization under the 510(k) Third Party Review Program. Within its recognized scope, GTPR conducts the primary review of eligible Class I and Class II 510(k) submissions and forwards its assessment and recommendation to FDA.

The authoritative, always-current record of recognized organizations and the product codes each may review is published by FDA. GTPR's recognition can be confirmed directly on FDA.gov.

Verify on FDA.gov View Recognition Letter (PDF)Download Recognized Scope (PDF)

How to verify recognition & scope

FDA organizes the program around recognized organizations and the exact product codes each is eligible to review. Three FDA sources establish the record:

Recognized organizations

FDA's current list of recognized 3P510k Review Organizations and the devices they may review.

Eligible devices

FDA's list of device types eligible for Third Party review, by panel and CFR.

Product classification

FDA's product-code database for classification, regulation and class.

Recognized scope

Search GTPR's recognized product codes by panel, CFR, code or device. The authoritative record is maintained by FDA and may change.

Recognized product codes, by FDA device panel. Source: FDA, Current List of FDA-Recognized 510(k) Third Party Review Organizations (database updated November 2, 2026).
Panel	CFR	Product code	Device	Class

Scope note: Eligibility depends on FDA Third Party program eligibility and GTPR's current recognized scope. Recognized scope is defined by FDA and is verifiable on FDA.gov. Listing a device type does not guarantee acceptance of a specific submission.

Confirm whether your device falls within GTPR's recognized scope.

Start with an eligibility determination.

Check Device Eligibility