FDA Draft Guidance on Medical Device Establishment Inspections

The FDA has issued a draft guidance regarding how it will implement uniform processes and standards that are applicable to inspections (other than for-cause) of foreign and domestic medical device establishments.

The FDA updated processes and standards to address the new provisions in 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 This draft guidance also describes standardized methods of communication during the inspection process and identifies practices for investigators and device establishments to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 do not establish legally enforceable responsibilities. Instead, guidance describes the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

Interested parties may submit comments and suggestions regarding this draft document within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions about this document contact the ORA Office of Strategic Planning and Operational Policy (OSPOP) at ORAPolicyStaffs@fda.hhs.gov.