FDA guidance proposes devices be deemed adulterated for refusing inspections

The US Food and Drug Administration’s (FDA) has issued draft guidance proposing that devices be deemed adulterated and refused entry to the US market if companies refuse to allow inspections of their facilities without adequate justification. Under current FDA policy, only drugs can be deemed adulterated if FDA inspectors are barred at the door.

The draft align with an update in the law under the FDA Reauthorization Act (FDARA), which requires devices also be deemed adulterated and refused entry for staff that block FDA inspections.

The draft guidance defines the types of actions that constitute unreasonable conditions for delaying denying or limiting an inspection.

The revised draft is almost identical to the 2014 final guidance on circumstances for delaying or denying an inspection, except that it incorporates the FDARA provisions. The law also required FDA to issue final guidance outlining the circumstances that constitute unjustified refusals a year after issuing a draft guidance.

The October 2014 guidance will remain in effect until this draft is finalized.

The guidance covers four general areas: delays of inspections, denials of inspections, limiting inspections and refusing to permit entry of inspections.

These situations can include facilities not agreeing to an announced inspection start date and failing to give a “reasonable explanation” why. It can also include a facility requesting a later start date without offering a reasonable explanation.

Other situations include leaving FDA investigators in a conference room without access to necessary documentation.

Other more egregious examples include a facility rejecting FDA’s attempt to schedule a preannounced inspection, or upon arrival, the facility does not allow FDA investigators to inspect the facility.

The agency is “particularly interested” in comments on including devices to the October 2014 guidance, said an announcement.

The earlier guidance incorporates the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), which mandates that drugs can be deemed adulterated if manufacturers unreasonably delay, deny or limit an inspection, or refuse to permit entry or inspection. The law required FDA to issue guidance that defined these circumstances that would constitute delaying an inspection.

The deadline for submitting comments is 14 February 2023.

FDA draft guidance

FDA guidance proposes devices be deemed adulterated for refusing inspections

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