FDA Third Party Review

The FDA came up with the FDA Third Party Review to make it easier to deal with the large number of 510(k) requests from medical device manufacturers seeking to determine whether their manufactured medical devices are substantially equivalent (SE) or not substantially equivalent (NSE). FDA Third Party Review Program is targeted at decongesting FDA’s administrative workload and intends to increase the speed of 510(k) decisions.

Accredited FDA Third-Party Assess Organizations are permitted to review some low-to-moderate risk medical devices under the 510(k) Third Party Review Program, which offers medical device manufacturers a voluntary alternative review method. With the program, the FDA will be able to concentrate its resources on higher-risk devices and make 510(k) decisions more quickly while still keeping control over the review of lower-risk devices that qualify for third-party review. This program is formally known as the Accredited Persons Program.

Use of this program is voluntary. The FDA accepts about 50 percent of 510(k)s that qualify for this program. There is no separate payment (i.e. user fee) to the FDA; the only payment made under the program is between the 510(k) submitter and the 3P510k Review Organization.

The Four basic steps to submit file through FDA Third Party review organization.

1. Determine if your device is eligible.

To determine if a 510(k) submission is eligible to be reviewed under the Third-Party review Program, the 510(k) submitter can do any of the following:

- Review the list of eligible devices for the device product code (most Class I and Class II devices are eligible);
- Search the FDA’s Device Classification Database.
- Contact a Third-Party review organization 3P510k or
- Contact the FDA at 3P510k@fda.hhs.gov.

2.Find and contact a 3P510k review organization that can review your 510(k).

A 510 (k) submitter can use either of the methods below to find and contact organizations that can review their 510(k) submissions:

- Access the List of Devices for FDA Third Party Review page and then:
  - Click on a device type at the bottom of the page. This will display a table with regulation names and product codes; and
  - Click on the product code of the device. This will display additional information for the product code, including a list of any 3P510k review organizations that are eligible to review that type of device.
- Review the list of 3P510k review organizations (also referred to as Accredited Persons). The list of 3P510k review organizations shows the devices each organization is accredited to review, and their contact information.

3.Obtain price quotes from one or more 3P510k review organizations and make a contract for a review.

The fee for a review is determined by the agreement between the 510(k) submitter and the Review Organization. The 510(k) submitter pays the fee directly to the 3P510k Review Organization. The FDA does not collect a user fee for third-party submissions.

4.Submit the 510(k) to the 3P510k review organization. The submission should include the following:

A letter authorizing the 3P510k review organization to discuss the 510(k) with the FDA and to forward it to the FDA on the 510(k) submitter’s behalf. The letter should include:

Name of the 3P510k review organization.
Name and contact information of the person assigned to the review; and
Device trade name.

The complete 510(k) submission, including the supporting data, summaries and analysis in the format requested by the 3P510k review organization.

The same standards used by the FDA to evaluate 510(k) submissions are used by 3P510k Review Organizations. To make sure a 3P510k review organization is following the most recent standards and recommendations applicable to that type of device, the review process may involve early involvement with the FDA.

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