Since July 9, 2012, the day that the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public 19 Law 112-144) was signed into law, drug products are deemed “adulterated for which a manufacturer processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.”  In response to that legislation, FDA issued a 2014 guidance entitled Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.

On August 18, 2017, the day that the FDA Reauthorization Act of 2017 (FDARA) (Public 29 Law 115-52) was signed into law, the same “deemed adulterated” provisions apply to devices.  The FDA was also required to issue a guidance to address devices under those provisions, and it did that today by issuing a draft guidance titled Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection.

However, the FDA says that the 2014 guidance shall remain in effect until this newly revised draft guidance is finalized.

The guidance explains the circumstances under which the FDA will consider inspections to be hindered such as to trigger the adulteration finding, and covers these four general areas in great detail:

  • Delay of inspection
  • Denial of inspection
  • Limiting of inspection
  • Refusal to permit entry or inspection

The addition of devices to this guidance is significant and will result in equal treatment of drugs and devices, relative to the provisions of the two pieces of legislation cited above, as the Agency tightens up its guidance on inspectional issues for both drugs and devices.