Medical Devices Get Added to FDA’s Inspection Delay Guidance

The FDA could deem a medical device adulterated if its manufacturer refuses an agency inspection without a reasonable explanation, under draft guidance announced Thursday.

The proposal would incorporate medical device products into the Food and Drug Administration’s existing guidance for drugmakers outlining the circumstances under which manufacturers could reasonably delay or limit facility inspections, according to a Federal Register notice. The recommendations, which were finalized for drugmakers in 2014, help the agency ensure that manufacturers, processors, and packagers don’t attempt to conceal or remove certain records or components of a facility that are necessary for the FDA to review. ...