510(k) Third Party Review Program Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations March 2020
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
The 510(k) Third Party (3P510k) Review Program (formally known as the Accredited Persons (AP) Program) is authorized under section 523 of the Federal Food, Drug, and Cosmetic (FD&C) Act.1 Under this authority, FDA recognizes third parties to review premarket notification (510(k)) submissions and recommend the initial classification of certain devices. FDA's implementation of section 523 establishes a process for recognition of qualified third parties to conduct the initial review of 510(k) submissions for certain low-to-moderate risk devices eligible for review under the 3P510k Review Program within the Center for Devices and Radiological Health (CDRH).2This guidance document also reflects amendments made to section 523 by the FDA Reauthorization Act of 2017 (FDARA),3 which directed FDA to issue guidance4 on the factors that will be used in determining whether a class I or class II device type, or subset of such device types, is eligible for review by an accredited person.
For the current edition of the FDA-recognized standards referenced in this document, see the FDA Recognized Consensus Standards Database.5 For more information regarding use of consensus standards in regulatory submissions, please refer to FDA guidance entitled, "Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices".6
The objectives of this guidance are:
- To describe the factors FDA will use in determining device type eligibility for review by 3P510k Review Organizations
- To outline FDA's process for the recognition, rerecognition, suspension, and withdrawal of recognition for 3P510k Review Organizations
- To ensure consistent quality of work among 3P510k Review Organizations through the Medical Device User Fee Amendments (MDUFA) IV commitments authorized under FDARA7 to eliminate the need for routine, substantive re-review by FDA.8
1 Section 523 of the FD&C Act uses the terms "accredited persons," "accredit," "accredited," "accreditation," "reaccredit," "reaccredited," and "reaccreditation." The guidance does not use those statutory terms but rather defines such terms as "recognition," and "rerecognition" as synonymous terms. These alternative terms are used in this guidance to harmonize the terms used by FDA and in the FD&C Act with those in the International Medical Device Regulators Forum (IMDRF) Medical Device Single Audit Program (MDSAP) documents and are defined in Section IV of this guidance.
2 Currently, the Center for Biologics Evaluation and Research does not regulate devices of the types subject to this guidance.
4 See section 523(a)(3)(B) of the FD&C Act.
5 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
6 See Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.
8 See Eliminating Routine FDA Re-Review of Third Party 510(k) Reviews.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2016-D-2565.