Training, Guidance, and Other Resources for Third Party Review Organizations
Update - December 21, 2023: The U.S. Food and Drug Administration (FDA) issued the draft guidance 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review. The updated draft guidance describes expectations for third party review of 510(k) submissions and EUA requests. When final, this guidance will supersede the “510(k) Third Party Review Program” guidance. Read the guidance and learn how to submit comments.
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.
- 510(k) Third Party Review Program - Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations
- Guidance Documents (Medical Devices and Radiation-Emitting Products)
Other Resources
Additional information on FDA.gov may also be useful for third-party reviewers including:
- Review Memos for Third Party 510(k) Reviewers
- Eliminating Routine FDA Re-Review of Third Party 510(k) Reviews (PDF - 223KB)
- 510(k) Third Party Performance Metrics and Accreditation Status
- Device Advice: Premarket Notification 510(k)
- FDA Recognized Consensus Standards Database
- Releasable Premarket Notification 510(k) Database
- 510(k) Clearances
- Product Classification Database