FDA issued part one of a planned series of draft guidance documents Feb. 15 detailing the accreditation and re-accreditation process for firms under the third-party review program. The program accredits third-party reviewers to review 510(k)s for certain low-to-moderate risk devices, freeing up time for FDA staff to review higher-risk and complex devices. The guidance uses recognized criteria described in a draft guidance issued last December by the International Medical Device Regulators Forum on recognition criteria for medical device auditing organizations. (See Also see "As GHTF Ends, Industry Cautiously Optimistic On Future Harmonization Progress Under IMDRF" - Medtech Insight, 5 November, 2012..) FDA intends to incorporate information from the IMDRF document in subsequent draft guidance documents to the extent appropriate as part of the criteria for accreditation of reviewers under the third-party review program. Comments on the guidance are due April 16.
FDA released a final guidance document Feb. 15 on clinical study designs for surgical ablation systems to treat...
