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  7. How to Submit a 510(k) Through the Third Party Review Program
  1. Premarket Submissions

How to Submit a 510(k) Through the Third Party Review Program

How to Submit a 510(k) Through the Third Party Review Program

There are four basic steps to submit a 510(k) through the program.

  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 one of the following:

  2. Find and contact a Review Organization that can review your 510(k).

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

    • Access the List of Devices for 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 review organizations that are eligible to review that type of device.
    • Review the list of Review Organizations (also referred to as Accredited Persons). The list of Review Organizations shows the devices each organization is accredited to review, and their contact information.
  3. Obtain price quotes from one or more 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 Review Organization. The FDA does not collect a fee for third party submissions.
  4. Submit the 510(k) to the Review Organization. The submission should include the following:
    • A letter authorizing the 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:
      1. Name of the Review Organization;
      2. Name and contact information of the person assigned to the review; and
      3. Device trade name.
    • The complete 510(k) submission, including the supporting data, summaries and analysis in the format requested by the Review Organization.