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