Establishment Registration
Establishment Registration is the FDA requirement that companies manufacturing, processing, or distributing drugs or medical devices for the U.S. market annually list their facilities and products, enabling agency oversight, inspection scheduling, and tracking of regulated establishments.
What is Establishment Registration?
Establishment Registration is a U.S. Food and Drug Administration (FDA) requirement that companies which manufacture, process, or distribute drugs or medical devices for the U.S. market identify their facilities to the agency. Registrants list both their establishments and the products they handle, and they renew this information on a defined, typically annual, basis.
The registration creates an official record of who is making or distributing regulated products and where. It is an administrative obligation distinct from the separate approvals or clearances a product itself may require.
Why is Establishment Registration important?
Knowing which facilities are active and what they produce allows the FDA to schedule inspections, monitor the supply chain, and track regulated establishments. The registry is a foundational tool for the agency's oversight of drug and device makers.
For manufacturers and distributors, maintaining current registration is a condition of legally supplying the U.S. market. Lapses or inaccuracies can disrupt the ability to ship products and can draw regulatory attention.
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