FDA, 510(k) Third Party Review Program

The 510(k) Third Party Review Program provides a voluntary alternative review process to medical device manufacturers and is a review by 510(k) submitted to an authorized third party review body (3P510k review body).
The products covered by this program are specific low-risk medical devices, which allow the FDA to focus on high-risk devices, while maintaining review supervision of low-risk medical devices subject to third-party review and faster review.

For more information, please refer to the link below.

Refer from https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/510k-third-party-review-program

 

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