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The FDA issued draft guidance on the 510(k) Third-Party Review Program Friday, focusing on accreditation of reviewers and providing a far greater level of detail, at 34 pages, than the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

An initial step in the harmonization process is a set of standard definitions — for example, outlining the difference between a “product specialist” and a “technical expert.”

The agency notes that companies can always send 510(k) submitters directly to the FDA, but only those that use accredited third-party reviewers are eligible for FDA review within 30 days.

The guidance outlines the steps of the 510(k) review process:

• Determine device eligibility for third-party review;
• Obtain relevant FDA guidance and information;
• Consult with the relevant FDA branch chief (as needed);
• Ensure a submission is administratively complete;
• Select the appropriate product specialist and technical expert to conduct the substantive review;
• Conduct the substantive review;
• Identify the deficiencies in the submission;
• Document the review;
• Organize and document the submission;
• Submit additional information upon the FDA’s request; and
• Dispute resolution.

Read the 510(k) guidance document here: www.fdanews.com/09-09-16-thirdpartyreview.pdf.