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New Fees and Registration Requirements for U.S. Drug and Medical Device Importers

The new U.S. Food and Drug Administration Safety and Innovation Act, recently passed in both the House and the Senate, will increase the information and fees required from U.S. drug and medical device importers and manufacturers.

This bill amends the Federal Food, Drug, and Cosmetic Act to revise and extend user-fee programs for prescription drugs and medical devices.  The bill introduces new fees for drug and medical device manufacturers, including user-fee programs for generic drugs, medical devices, biosimilar biologics, medical gases and innovator drugs.  The Act establishes new fees for Type II Active Pharmaceutical Ingredient (API) Drug Master Files (DMF) and gives FDA the authority to block access to your DMF if the fee is not paid.

The changes in registration include, requiring additional data for drug establishment registration and listings, mandating the identification of manufacturers of excipients of listed drug products, and moving the registration period to the fourth quarter of each year.  U.S. drug importers will now be required to register for the first time.

Once the bill is signed by President Obama, thus becoming U.S. Law, Registrar Corp will provide a “Top Ten List” of things that Industry needs to know about the Food and Drug Administration Safety and Innovation Act.

For more information the new U.S. Food and Drug Administration Safety and Innovative Act or any FDA regulation, please contact Registrar Corp





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