USA – Guidance : Review and Update of Device Establishment Inspection Processes and Standards

FDA is issuing this guidance to comply with section 702(b)(2) of the FDA Reauthorization Act of 2017 (FDARA) (Public Law 115-52), which directs FDA to issue guidance that specifies how the Agency will implement uniform processes and standards that are applicable to inspections (other than for-cause) of foreign and domestic device establishments. FDA updated processes and standards as needed to address the new provisions in section 704(h)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that were added by FDARA section 702(a) and to establish a standard timeframe for inspections. This guidance also describes standardized methods of communication during the inspection process and identifies practices for investigators and device establishments to facilitate the continuity of inspections of such establishments.

FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required…