U.S. FDA [510(k)] Third Party Review

The FDAMA (FDA Modernization Act), 1997 base on a pilot program from USFDA had launched.The U.S. Food and Drug Administration (FDA) [510(k)] Third Party Review Program is a voluntary program that allows certain medical device manufacturers to have their 510(k) submissions reviewed by an accredited third-party organization (3P510k Review Organization) instead of directly by the FDA. This program is intended to help expedite the review of low-to-moderate risk devices and allow the FDA to focus its resources on higher-risk devices.

Overview of The Program:

• Eligibility : Only certain low-to-moderate risk devices are eligible for third-party review. The FDA maintains a list of eligible devices on its website.
• Process : Manufacturers submit their 510(k) submissions to a 3P510k Review Organization of their choice. The 3P510k Review Organization reviews the submission and makes a recommendation to the FDA on whether to grant or deny clearance.
• FDA review : The FDA reviews the 3P510k Review Organization’s recommendation and makes a final decision on the 510(k) submission.