510(k) Guidance Specifics Recognition Process for Third-Party Reviewers

The FDA issued draft guidance on the 510(k) Third-Party Review Program Friday, focusing on accreditation of reviewers and providing a far greater level of detail, at 34 pages, than the eightpage version issued in 2013.

The guidance is intended to provide a comprehensive look at the agency’s current thinking on third-party reviews of devices in the 510(k) program, encouraging global harmonization by incorporating elements of the International Medical Device Regulators Forum’s single-audit program. It cites four documents from the forum’s Medical Device Single Audit Program as relevant to the draft current guidance. All four focus on assessment and recognition of auditing organizations.

The forum is developing a fifth document, “Competency, Training, and Conduct Requirements for Regulatory Reviewers,” that will provide additional detail on the accreditation process, the FDA said. — Jim Stimson