Recently, the U.S. Food and Drug Administration (FDA) issued this 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.
Key highlights of this final guidance:
- FDA Expectations: Clarifies the FDA’s expectations for both the 510(k) Third Party Review Program and EUA third party review.
- Eligibility and Processes for 510(k) Third Party Review Organizations: Details factors for device eligibility and the procedures for recognizing, rerecognizing, suspending, and withdrawing recognition for 510(k) Third Party Review Organizations.
- Quality and Consistency: Outlines the FDA’s expectations for review to ensure confidence and consistent quality of work by Third Party Review Organizations to reduce the need for routine, substantive re-reviews by the FDA.
- Conflict Prevention: Outlines measures to prevent conflicts of interest between Third Party Review Organizations and other entities.
- Compensation Details: Provides information on the compensation process for Third Party Review Organizations.
| Read the Guidance |
