FDA 510(k) Glossary · submission

Third-Party Review

Third-party review is an FDA program under which accredited private organizations - authorized by the FDA - may conduct the substantive review of selected lower-risk 510(k) submissions, typically reducing total review time compared to standard FDA review. Established by the FDA Modernization Act of 1997.
Dataset Insight - 510k Database (166,200 records, 1980–2025)
3,434 of 166,200 submissions (~2.1%) used third-party review. Recent annual volumes: 68 (2022), 68 (2023), 54 (2024), 60 (2025). Uptake remains stable but limited.

Definition

The Third-Party Review Program (also known as the Accredited Persons Program) was established by the FDA Modernization Act of 1997. It allows FDA-accredited private organizations to review 510(k) submissions for certain lower-risk Class II devices on behalf of the FDA. The FDA retains authority over the final clearance decision.

Process

  1. The manufacturer selects an FDA-accredited third-party reviewer from the FDA published list.
  2. The third party conducts a substantive review and submits a recommendation (SE or NSE) to the FDA.
  3. The FDA makes its final clearance decision, typically within 30 days of receiving the recommendation.

Eligibility

Third-party review is available for a defined subset of lower-risk Class II devices. The FDA publishes and periodically updates the list of eligible device types. Devices involving novel intended uses, significant software components, cybersecurity requirements, or unresolved safety questions are generally not eligible.

Submission Volume Trend

Based on 510k Database records enriched from FDA accessdata.gov, third-party reviewed submissions have maintained a stable volume of approximately 54-68 per year in recent years, suggesting consistent but limited uptake of the program.

YearSubmissions
202623
202560
202454
202368
202268

2026 is a partial year. Data from 510k Database enriched records only.

Search third-party reviewed submissions in the database

Academic Context

A 2023 analysis by Kramer and Yeh published in the Journal of the American College of Cardiology examined the Third-Party Review Program and noted that uptake has remained limited despite its potential to reduce FDA review burdens - consistent with the stable low volumes observed in the dataset.

FDA References

Related Terms

510(k) Premarket Notification - Substantial Equivalence - Predicate Device - De Novo Classification

Frequently Asked Questions

Third-party review is a program established by the FDA Modernization Act of 1997 that allows FDA-accredited organizations to conduct the substantive review of eligible 510(k) submissions. The FDA retains authority over the final clearance decision but delegates the review itself to the accredited third party.

Eligibility is limited to certain lower-risk Class II devices without novel technological characteristics. The FDA publishes a list of eligible device types. Devices with new intended uses, complex software, cybersecurity requirements, or unresolved safety questions are generally not eligible.

Yes, typically. Third-party reviewed submissions often achieve shorter total review cycles because the third-party reviewer can begin immediately without the FDA's internal queue. The FDA must then make its final decision within 30 days of receiving the third-party recommendation.

Based on 510k Database records enriched from FDA accessdata.gov, 3,434 submissions in the dataset (~2.1% of all submissions) used FDA-accredited third-party review.