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# Streamlining Third-Party Device Reviews
- URL: https://www.fdaweb.com/streamlining-third-party-device-reviews/
- Published: 2018-09-13T12:00:00.000Z
- Updated: 2026-09-15T00:31:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142342

FDA says it is issuing a comprehensive plan to streamline agency review of medical device premarket submissions that have already undergone a review by qualified expert third parties. The [plan](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/ThirdParyReview/UCM620308.pdf?ref=fdaweb.com) sets a goal of having at least 85% of Third Party (3P) Review Program submissions proceed without substantive FDA re-review by the end of FY 2021\. It says the goal will be achieved by **(1)** ensuring the device types eligible for the 3P review program are appropriate; **(2)** giving 3P Review Organization (3PRO) reviewers the tools they need to succeed; **(3)** providing a way for 3PROs to demonstrate that they can successfully apply FDA’s criteria for reviewing a 510(k) submission; **(4)** implementing a comprehensive framework for FDA processing of 3PRO 510(k) submission packages; and **(5)** using program measures to monitor the 3P Review Program, adjusting as necessary to ensure sure goals are met, and using continuous process improvement activities to identify and implement improvements where appropriate.

Commenting on the plan, FDA commissioner **Scott Gottlieb** says that for eligible submissions, FDA will review the expert recommendations of the third party to make its final decision and generally will not re-review the submission itself. “Leveraging high quality, FDA-equivalent outside reviews for lower-risk products can improve FDA’s overall productivity and enable the agency to focus more of its time and resources on evaluating applications for higher-risk and more complex devices,” he says.

The agency also issued a draft guidance, *501(k) Third Party Review Program*, a reissuance of a 9/12/16 guidance that when final will supersede guidances from 2001 and 2004\. The [document](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM339697.pdf?ref=fdaweb.com) reflects amendments made to the 3P Review Program by the FDA Reauthorization Act of 2017, which directed the agency to issue draft guidance on the factors that will be used in determining whether a Class 1 or Class 2 device type, or subset of such device types, is eligible for review by an accredited person. The guidance is intended to **(1)** describe factors FDA will use in determining device type eligibility for review by 3PROs; **(2)** outline the agency’s process for the recognition, re-recognition, suspension, and withdrawal of recognition for 3PROs; and **(3)** ensure consistent quality of work among 3PROs through the MDUFA 4 commitments authorized under the FDA Reauthorization Act.

Gottlieb says the guidance is to provide clarity and transparency for industry and FDA-recognized 3PROs. “The goal is to make the evaluation of certain lower-risk medical devices more efficient,” he says, “while maintaining FDA’s gold standard for product review.”