FDA finalizes guidance extending inspection authority to medical devices

BY LAURA DIANGELO, MPH

Under the Federal Food, Drug and Cosmetic Act, facilities may not deny, delay or limit FDA inspections of facilities, or else the products they make may be considered adulterated. While this policy has been in place since 2012 for drug facilities, the same authority was only extended to FDA’s oversight of medical devices in 2017. The FDA has now finalized a revision to its guidance on the subject to provide more examples and incorporate device considerations.

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