End-to-End FDA Registration & Compliance Services

Foreign facilities or establishments that are required to register under the applicable food, drug, medical device, or cosmetic program generally provide U.S. Agent information as part of registration. The exact U.S. Agent duties differ by FDA program, but the role serves as a U.S.-based communications link between FDA and the foreign firm.

Renewal timing varies by program. Food facility registrations are renewed from October 1 through December 31 of each even-numbered year. Drug establishments renew annually between October 1 and December 31. Medical device establishments register annually and review listing information during the annual registration period. Cosmetic facilities that are required to register renew biennially. A missed deadline can cause a registration to expire or lapse and may affect U.S. marketing or import activity depending on the program.

FSVP applies to the FDA-defined FSVP importer of covered imported food unless an exemption or modified requirement applies. The FSVP importer is generally the U.S. owner or consignee of the food at entry; if there is no U.S. owner or consignee, a qualifying U.S. agent or representative of the foreign owner or consignee can serve in that role with the required consent. Covered importers may need hazard analysis, supplier evaluation, verification activities, corrective actions, and records.

Timing varies by FDA program and by the completeness of the facility, product, identifier, and U.S. Agent information. FDA Registration Assistance typically prepares many routine registration projects within 24–48 hours after complete information is available, but FDA processing, identifier verification, user-fee steps, or program-specific requirements can affect the final timeline.

The information depends on the FDA program. Food facility registration commonly requires facility, owner/operator, UFI, food-category, and U.S. Agent information when applicable. Drug registration and listing use electronic SPL submissions and establishment identifiers. Device registration and listing require owner/operator and establishment information, device listings, and annual user-fee steps where required. MoCRA facility registration and cosmetic product listing require facility, product, responsible-person, ingredient, and U.S. Agent information as applicable.

Selling through Amazon, Shopify, eBay, or another online channel does not create a blanket exemption from FDA requirements, but it also does not mean every seller needs its own facility registration. The obligations depend on the product, the physical facility activities, the importer or responsible-person role, and the specific FDA program. Online sellers may still have FSVP, Prior Notice, labeling, product-listing, importer, or other compliance responsibilities.

The correct response depends on the Import Alert, detention reason, product, entry history, and underlying compliance issue. A case may involve testing, labeling corrections, registration or listing fixes, supplier corrective actions, documentation, or a request for removal from detention without physical examination when an FDA removal pathway is available. The first step is to identify the exact FDA basis for the action and build the response around that requirement.

The Modernization of Cosmetics Regulation Act of 2022 expanded FDA's authority over cosmetics. Covered cosmetic facilities must register and renew biennially, responsible persons must list marketed cosmetic products and update listings annually, and additional requirements address safety substantiation and serious adverse-event reporting. Certain small businesses and specified products may qualify for exemptions or different requirements.