Establishment Registration
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
Establishment registration is the mandatory identification of a facility that manufactures, prepares, propagates, compounds, or processes a regulated drug or device to FDA, giving the agency a current inventory of sites subject to inspection. It is a listing obligation, not a quality or approval standard, and is typically paired with product listing for drugs or device listing for devices.
Drug establishments register annually and update information as changes occur; the registration itself does not evaluate or approve the facility — it exists so FDA can schedule and prioritize inspections and correlate a specific product back to the facility that made it. Foreign establishments manufacturing drugs or devices for the US market must register and, for drugs, typically designate a US agent.
For devices, registration is paired with a device listing identifying which device types the establishment handles, and both drug and device registrations carry an annual user fee. Failure to register can itself be a basis for FDA to refuse entry of imported product or to consider the product misbranded.
- —Mandatory identification of a manufacturing/processing site to FDA, renewed annually
- —A listing obligation, not an approval — does not itself certify compliance
- —Foreign establishments serving the US market must register and often designate a US agent
- —Paired with drug listing (drugs) or device listing (devices)
- —Failure to register can support refusal of entry or a misbranding finding
FD&C Act §510; 21 CFR Part 207 (drug establishment registration and listing); 21 CFR Part 807 Subpart B (device establishment registration)
Frequently asked questions
What is Establishment Registration?
Establishment registration is the mandatory identification of a facility that manufactures, prepares, propagates, compounds, or processes a regulated drug or device to FDA, giving the agency a current inventory of sites subject to inspection. It is a listing obligation, not a quality or approval standard, and is typically paired with product listing for drugs or device listing for devices.
Which regulations cover Establishment Registration?
FD&C Act §510; 21 CFR Part 207 (drug establishment registration and listing); 21 CFR Part 807 Subpart B (device establishment registration)