FDORA implements new FDA requirements for foreign drug and medical device companies

Lexology January 18, 2023
DLA Piper

On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023 into law, which contains the Food and Drug Omnibus Reform Act (FDORA). FDORA includes a number of significant changes to the federal Food, Drug and Cosmetic Act (FDCA).

With specific regard to foreign manufacturers and importers of drugs and medical devices, FDORA contains new requirements for registration, inspections and certifications. FDA-registered foreign drug and device companies should take note of these new provisions immediately and begin adjusting their operations to reduce the risk of business interruption.

• Additional registration requirements for foreign establishments importing products to the USCurrently, only foreign establishments that import (or offer for import) drugs or devices directly into the US are required to register...

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