Releasable establishment registration and listing information under the Freedom of Information Act is available by searching the Establishment Registration and Listing database.

Dec 29, 2025 · Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its …

Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases …

Jul 17, 2025 · This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended …

Oct 31, 2023 · FDA Industry Systems (FIS) was created to facilitate making submissions to the U.S. Food and Drug Administration (FDA), including registrations, listings, and other notifications.

Domestic and foreign establishments that manufacture, repack, or re-label drug and biologic products, including vaccines, are required to register with the FDA.

Accuracy and integrity of establishment registration and drug listing data are essential to FDA’s … electronic prescribing and reimbursement rely upon registration and listing information.

Sep 24, 2025 · Product-Specific Guidances for Generic Drug Development Database More Information Purple Book (database of FDA-licensed (approved) biological products, including …

Jan 31, 2025 · FDA Databases: a listing of public databases for regulations, good practices, medical devices, drug and cosmetics products.

FDA will not issue a Registration Certificate after completing food, drug, medical device, cosmetic, or blood establishment registrations. The table below provides the direct link to the FDA …