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FDA guidance proposes devices be deemed adulterated for refusing inspections (Cell and Gene Therapy Catapult – Regulatory Round-up – December 2022)

The US Food and Drug Administration’s (FDA) has issued a draft guidance proposing that devices to be regarded as adulterated and refused entry to the US market if companies refuse to allow inspections of their facilities without adequate justification. According to the current FDA policy, only drugs can be considered adulterated if FDA inspectors are refused to carry out inspections.

The draft guidance defines the types of actions that constitute unreasonable conditions for delaying denying or limiting an inspection. It aligns 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 deadline for submitting comments is 14 February 2023.

See all of Catapult’s Regulatory Round-up for December 2022 here. Published on the 11th of January 2023.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (17 mai 2023). FDA guidance proposes devices be deemed adulterated for refusing inspections (Cell and Gene Therapy Catapult – Regulatory Round-up – December 2022). ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/o6aw


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