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U.S. Food and Drug Administration
  1. Home
  2. Medical Devices
  3. Device Advice: Comprehensive Regulatory Assistance
  4. How to Study and Market Your Device
  5. Premarket Submissions: Selecting and Preparing the Correct Submission
  6. 510(k) Third Party Review Program
  7. How to Submit a 510(k) Through the Third Party Review Program
  1. 510(k) 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 any of the following:

  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 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:
      1. Name of the 3P510k 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 3P510k Review Organization.
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