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  5. Premarket Submissions: Selecting and Preparing the Correct Submission
  6. 510(k) Third Party Review Program
  1. Premarket Submissions: Selecting and Preparing the Correct Submission

510(k) Third Party Review Program

Update: August 19, 2022: If manufacturers are considering seeking 510(k) clearance for personal protective equipment, most masks (such as product code FXX) and gloves (such as product codes LYY, LYZ, LZA, KGO, and LZC) are eligible for 510(k) Third Party Review.

Overview

The 510(k) Third Party Review Program provides medical device manufacturers with a voluntary alternative review process, in which accredited Third Party Review Organizations (3P510k Review Organizations) are allowed to review certain low-to-moderate risk medical devices. The program is intended to help yield more rapid 510(k) decisions and to allow the FDA to focus its resources on higher risk devices, while still maintaining oversight of the review of lower risk devices eligible for third party review. This program is formally known as the Accredited Persons Program.

An overview of the process to submit a 510(k) through the third party review program. 1.Review Organization receives file from 510(k) Submitter. 2.FDA receives and reviews recommendation and documentation from Review Organization. 3.FDA makes final decision (the FDA may make additional information request and put submission on hold). 4.FDA informs Review Organization of final decision. 5.Review Organization informs 510(k) Submitter of final decision.

Under the Third Party Review Program, a 510(k) submission for an eligible device may first be submitted to an accredited 3P510k Review Organization rather than directly to the FDA. Use of this program is voluntary. Approximately half of 510(k)s the FDA receives are eligible for this program. The sole payment under the program is between the 510(k) submitter and the 3P510k Review Organization; there is no separate payment (i.e., user fee) to the FDA.

3P510k Review Organizations use the same criteria used by the FDA to review 510(k) submissions. A 3P510k Review Organization's review may include early interaction with the FDA to ensure the 3P510k Review Organization is using up-to-date standards and guidance relevant to that type of device. It may also include requests for additional information from the 510(k) submitter. After the 3P510k Review Organization is satisfied with its review and has documented all the necessary information for the submission, it sends the submission to the FDA including the original 510(k) submission, the 3P510k Review Organization's review, and a recommendation of either substantially equivalent (SE) or not substantially equivalent (NSE).

The FDA makes the final determination on the 510(k) submission based on the review and recommendation received from the 3P510k Review Organization. If the 3P510k Review Organization did not appropriately apply the 510(k) decision criteria or if there are substantive review quality issues with their documentation, the FDA may need to re-review all or part of the 510(k) submission. However, the FDA is updating this program to avoid the routine re-review of 510(k) submissions already reviewed by a 3P510k Review Organization.

Learn how the FDA is eliminating the routine re-review of 510(k) submissions.

The FDA's review timeframe for a MDUFA decision is within 30 days after receiving the recommendation of a 3P510k Review Organization.



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