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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
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  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. Training, Guidance, and Other Resources for Third Party Review Organizations
  1. 510(k) Third Party Review Program

Training, Guidance, and Other Resources for Third Party Review Organizations

UPDATE: November 20, 2024

The FDA issued a final guidance: 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review. This guidance supersedes the previous "510(k) Third Party Review Program" guidance, clarifying how the FDA will use third party review organizations to review 510(k) submissions and may use them to review EUA requests during a future public health emergency.

Third Party Review Organizations (3P510k Review Organizations) are responsible for preparing a review memorandum documenting the reasoning and steps that led to a Substantially Equivalent or Not Substantially Equivalent recommendation. The FDA relies on thorough and substantive review memos to make a final decision on a 510(k) submission.

The FDA has resources available to help 3P510k Review Organizations complete a satisfactory review of a 510(k) submission. We expect that 3P510k Review Organizations to take advantage of these documents by reviewing them before and during review of a 510(k) submission, as applicable.

Training

To help educate third-party reviewers on the regulatory framework, regulatory requirements, and review processes of a 510(k) premarket notification, the FDA developed a curriculum: Training Curriculum for Third-Party Reviewers. The core curriculum consists of courses for third-party reviewers to help achieve FDA-equivalent reviews. The curriculum also includes device-specific trainings for certain eligible device types.

These trainings include webinars, presentations, and guidance documents that are available online. They are listed in this document in an order that the FDA believes will be most helpful in building knowledge from general regulatory to technically specific topics.

Guidance

The FDA's guidance documents are a valuable resource for Third Party Review Organizations. While there are guidance documents that are specifically about the Third Party Review program, third-party reviewers may also find other device program guidance documents helpful.

Other Resources

Additional information on FDA.gov may also be useful for third-party reviewers including:

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