Third Party Review Organizations (Review Organizations) are responsible for preparing a review memorandum documenting the reasoning and steps that led to an SE or NSE 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 Review Organizations complete a satisfactory review of a 510(k) submission. We encourage Review Organizations to check out these documents before and during review of a 510(k) submission, as applicable.
Training for Third Party Review Organizations
We recommend that Review Organizations watch the CDRH Learn modules in the 510(k) Third Party Program (for Third Party Review Organizations) section of the CDRH Learn page. The presentations in CDRH Learn are an excellent training resource for completing an effective review. The 510(k) Third Party Review Program: Overview module is a good place to start.
Device Type Specific Training for Third Party Reviewers
We are also developing learn modules with information tailored to specific device types to help review organizations conduct successful reviews.
Training resources tailored to specific device types will be included here when available.
The FDA’s guidance documents are a valuable resource for Third Party Review Organizations. While there are a number of guidance documents that are specifically about the Third Party Review program, Third Party Reviewers may also find other device program guidance documents helpful.
- Guidance for Third Parties and FDA Staff; Third Party Review of Premarket Notifications
- Implementation of Third Party Programs Under the FDA Modernization Act of 1997 - Final Guidance for Staff, Industry and Third Parties
- 510(k) Third Party Review Program - Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations (this guidance is not final and is not for implementation at this time)
- Guidance Documents (Medical Devices and Radiation-Emitting Products)
Additional information on the FDA’s website may also be useful for Third Party Reviewers.