Zdrowie i gospodarka · 12/09/2016

FDA Announces Draft Guidance for 510(k) Third Party Review Program

The Food and Drug Administration (FDA) has released a draft guidance document outlining its approach to the 510(k) Third Party Review Program, which aims to harmonize regulatory assessments with the International Medical Device Regulators Forum's Medical Device Single Audit Program, and outlines criteria for reaccrediting and denying reaccreditation of third-party review organizations.