FDA Compliance
Educational Center

Registration or listing requirements can apply to food and dietary supplement facilities, drug establishments, cosmetic facilities and products under MoCRA, and medical device establishments. The exact obligation depends on product classification and the establishment's activities. Exemptions may apply, and foreign-facility U.S. Agent requirements vary by program. Read the FDA guidance.

Domestic and foreign facilities that manufacture, process, pack, or hold food for consumption in the United States generally must register with FDA unless an exemption applies. Examples of exempt operations include qualifying farms, restaurants, and retail food establishments. Read the FDA guidance.

The FSVP importer is generally the U.S. owner or consignee of food at the time of entry. If there is no U.S. owner or consignee, a U.S. agent or representative of the foreign owner or consignee may serve as the FSVP importer with signed consent. This role is distinct from the U.S. Agent listed in a foreign food facility registration. FSVP applicability, exemptions, and modified requirements depend on the food and import circumstances. Read the FDA guidance.

A facility that manufactures, processes, packs, or holds dietary supplements for U.S. consumption generally must register as a food facility unless an exemption applies. Dietary supplement labeling and applicable current Good Manufacturing Practice requirements are separate obligations. Read the FDA guidance.

Drug establishment registration generally applies to domestic and foreign establishments that manufacture, repack, or relabel drugs for the U.S. market. Applicable drug listings must also be maintained. Distribution alone does not automatically mean every distributor must register as a manufacturing establishment. Read the FDA guidance.

The National Drug Code identifies listed drug products. Labeler-code and listing responsibilities depend on the company's role in manufacturing, repacking, relabeling, or private-label distribution. An NDC number or drug listing is not FDA approval and does not, by itself, authorize a product to be marketed. Read the FDA guidance.

MoCRA generally requires covered cosmetic manufacturers and processors to register their facilities, while the Responsible Person must list covered marketed cosmetic products. Facility registrations are renewed every two years, and product-listing updates are provided annually. Certain small businesses and other activities may be exempt. Safety substantiation, labeling, and adverse-event obligations must also be assessed. Read the FDA guidance.

Many medical device manufacturers, contract manufacturers, specification developers, and other covered establishments must register and list devices. Requirements and exemptions depend on establishment activities and device classification. Covered foreign establishments must also identify a U.S. Agent. Registration and listing do not replace any required clearance, approval, or other authorization. Read the FDA guidance.

A U.S. Agent is a U.S.-based point of contact for a foreign establishment under the applicable FDA registration program. This role supports communications with FDA and is separate from an FSVP importer, customs broker, importer of record, or cosmetic Responsible Person unless the same entity separately agrees to and qualifies for those roles.

Renewal schedules vary by program. Drug and medical device establishment registrations require annual maintenance, while cosmetic facility registration is renewed every two years and cosmetic product-listing updates are provided annually. Food facilities follow their applicable renewal schedule. Confirm the deadline and any required updates for your specific registration. Read the FDA guidance.

If your registration is inactive or incorrect, your shipments may be held at the port of entry, delayed, or refused by the FDA. This can lead to storage fees, product loss, and disruption of your U.S. distribution. Maintaining an accurate and active registration is critical for smooth import operations.

Not all FDA-regulated products require premarket approval. Many products, such as conventional foods and most cosmetics, do not require FDA approval but must still comply with registration, labeling, and safety requirements. Certain medical devices and drugs do require premarket clearance or approval depending on their classification.

Amazon sellers must meet the FDA requirements that actually apply to their products and business activities, along with the marketplace's own policies. Not every seller must personally register a facility, but applicable registration, listing, labeling, safety, and import requirements still need to be addressed.

Timing depends on the FDA program, the completeness of the information, and whether review or additional authorization is needed. Straightforward electronic submissions can often be prepared quickly, but submission is not a guarantee of FDA acceptance, clearance, approval, or customs release.

Begin by identifying your product category and your facility's or company's role in the supply chain. Then determine applicable registration, listing, U.S. Agent, FSVP, labeling, and market-authorization requirements, including any exemptions. Our team can help organize the information and identify the appropriate next steps.