This resource is the US FDA (Food and Drug Administration) guidance on the 510(k) Third Party Review Program.
About this document
Under this program, eligible devices can first be reviewed by an FDA-recognised third-party review organisation (3P510k Review Organization), with the FDA then making the final decision – usually faster than submitting directly to the FDA. The guidance explains the scope of eligible devices, recognition requirements for third-party organisations and the process for submitting a 510(k) through a third party.
Applicable products and users
- Class I and Class II medical devices on the FDA’s list of devices eligible for third-party review
- Manufacturers wishing to shorten the 510(k) review cycle
Main contents
- Scope of devices eligible for third-party review
- Responsibilities and recognition requirements of third-party review organisations
- Process differences between third-party review and direct FDA review
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Related articles
- US FDA Medical Device 510(k) Submissions
- FDA Registration (Part 8): The eSTAR for FDA 510(k) Submissions Explained
- US FDA Medical Device Registration Services
Need help interpreting this document or assessing its impact on your product? EVERBIZ provides regulatory consulting and registration services – please contact us.
Note: this resource is for reference only. Please refer to the latest official version published by the issuing authority.