The Federal Food, Drug and Cosmetic Act prohibits facilities from denying, delaying or limiting FDA inspections in order to prevent their products from being considered adulterated. This policy has been in place for drug facilities since 2012, but was only extended to medical devices in 2017. The FDA has recently finalized a revision to its guidance on this subject, providing more examples and incorporating device considerations. To access the full article, readers must fill out a form.
June 23, 2024
Artificial Intelligence
FDAcop
