FDA does not register products at the border. It registers the places where products are made, packed or held, and it checks that registration against every FDA-regulated entry line. When a foreign supplier’s registration is missing, lapsed or tied to the wrong address, the shipment stops at the port regardless of how clean the goods are. For food, the law does not even allow release under bond until the facility registers.
FDA registration for foreign manufacturers is not one system. Food facilities, device establishments, drug establishments, cosmetic facilities and makers of radiation-emitting electronics each sit under a different part of the FD&C Act, with different renewal windows, different fees and different consequences when something is missed. What follows maps each regime, explains what the US Agent actually carries, sets out the food facility renewal window that opens on October 1, 2026, and covers what happens at the port when the registration is not there. Rules checked against eCFR text, fda.gov and the Federal Register as of September 23, 2026.
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Which Registration Applies: Food, Device, Drug, Cosmetic or Electronic Product
The product decides the regime, and some products trigger two. A laser used in surgery is both a medical device and an electronic product subject to a radiation performance standard, so its maker registers and lists as a device establishment and also files a product report with FDA’s radiological health program. Classify the product under FDA’s rules first, then check which facility obligations follow from it.
Food facilities
Every foreign facility that manufactures, processes, packs or holds food for US consumption registers under FD&C Act section 415 and 21 CFR 1 subpart H. The one exemption specific to foreign facilities covers a facility whose food is further processed or packaged by another foreign facility before export, and it does not apply when the second facility only labels or performs a similar de minimis activity (21 CFR 1.226(a)). A plant in Thailand whose product is relabeled in Singapore still registers. Farms, retail food establishments, restaurants, nonprofit food establishments, most fishing vessels and facilities regulated exclusively by USDA under the meat, poultry and egg products acts are exempt, wherever they are located. Importers building a food supply chain can see how this fits with the rest of entry compliance on our food and beverage import page.
Medical device establishments
Foreign manufacturers and foreign exporters of devices register and list electronically through FURLS under 21 CFR 807.40, in English, and name a single US Agent. The foreign firm must also identify each known importer and each person who imports or offers the device for import, which includes brokers (807.41). A US brand owner that has a foreign contract manufacturer build a private-label device to its specifications is a specification developer and registers and lists in its own right. The US importer that only furthers marketing without relabeling or repacking registers as an initial importer and identifies its foreign manufacturers under 21 CFR 807.20(a)(5); that role is covered on our FDA initial importer page.
Drug establishments
A foreign drug establishment must be registered before a drug it makes is imported (21 CFR 207.21(b)), and it lists the drugs it makes under the same part. FDA uses the DUNS number as the Unique Facility Identifier for drug registration. The registrant reviews and updates the record every year between October 1 and December 31, certifies when nothing has changed, and reports a change of US Agent or official contact within 30 calendar days (207.29). Registration itself carries no fee; GDUFA and OMUFA facility fees and PDUFA application and program fees are separate obligations.
Cosmetic facilities under MoCRA
MoCRA added FD&C section 607. Facilities operating on December 29, 2022 had to register by December 29, 2023, new facilities register within 60 days of starting operations, and changes are reported within 60 days. FDA began enforcing registration and listing on July 1, 2024. Registration renews every 2 years from the facility’s own initial registration date, not in a fixed national window, and product listings are updated annually, with new products listed within 120 days of marketing. Filing runs through Cosmetics Direct.
Small businesses with average US cosmetic sales under $1,000,000 over the prior 3 years (inflation-adjusted) are exempt, except for eye-area, injected, internal-use and long-wear appearance-altering products. FDA can suspend a facility registration when a product has a reasonable probability of causing serious adverse health consequences. Distributors sourcing from multiple contract fillers should hold every filler’s registration number on file, a point covered for importers on our cosmetics and chemical distributors page.
Radiation-emitting electronic products
Manufacturers of electronic products subject to a performance standard submit a product report before the product enters commerce (21 CFR 1002.10) and receive an accession number, transmitted at entry as the ACC Affirmation of Compliance (ANC for an annual report). The importer declares compliance on Form FDA 2877, sent electronically as the RA, RB, RC and RD codes. Every foreign manufacturer must designate a permanent US resident as agent for service of process before offering product for import (21 CFR 1005.25).
| Product | Legal basis | Cycle | US Agent | FDA registration fee |
|---|---|---|---|---|
| Food, dietary supplements, animal food | FD&C 415; 21 CFR 1 subpart H | Biennial, Oct 1 to Dec 31 of even years | Required | None |
| Medical devices | FD&C 510; 21 CFR 807 | Annual, Oct 1 to Dec 31 | Required, one only | $13,785 per establishment (FY2027) |
| Drugs and APIs | FD&C 510; 21 CFR 207 | Before first import, then annual review Oct 1 to Dec 31 | Required, one only | None for registration; user fee programs are separate |
| Cosmetics | FD&C 607 (MoCRA) | Every 2 years from the initial registration date | Required | None |
| Radiation-emitting electronics | 21 CFR 1002 and 1005 | Product report before entering commerce | Agent for service of process | None |
The US Agent: Role, Limits and Liability
Every foreign regime above requires a US-based representative, and most foreign suppliers treat the appointment as paperwork. It is more than that. For food and drugs, the US Agent must be physically present in the United States; a mailbox, answering service or virtual office does not qualify (21 CFR 1.227; 207.69(b)). The agent is FDA’s contact for routine and emergency communications, and FDA treats representations by the US Agent as those of the foreign facility. Documents delivered to the agent count as delivered to the facility.
Device rules (807.40(b)) and drug rules (207.69(b)) set the same core duties: assist FDA with communications, answer questions about the imported products, and help schedule inspections. Each device or drug establishment may name only one US Agent, and a change of device US Agent is reported within 10 business days. For cosmetics, FDA describes the role as limited to communications, product questions and inspection scheduling, again with delivery to the agent treated as delivery to the facility.
What the US Agent is not: it is not the importer of record, it does not file entries, and for devices it carries no registration or adverse-event reporting duty of its own while 21 CFR 803.58 remains stayed. The practical risk runs the other way. An agent who misses an FDA inspection request or records request leaves the foreign firm exposed, and FDA will not accept that the message never reached the plant. A foreign exporter without a US entity faces a related but separate question on the customs side, covered in our guide for the non-resident importer.
- Confirm the agent has a physical US address and a named person who answers FDA calls.
- Check that the agent named in the registration matches the one the supplier says it uses.
- Put response times for FDA requests in the agency agreement, not just the appointment.
The 2026 Food Facility Biennial Renewal Window
Food facility registrations renew every other year, from October 1 to December 31 of each even-numbered year (21 CFR 1.230(b)). FDA’s user guide confirms the 2026 window runs from October 1, 2026 at 12:01 a.m. to December 31, 2026 at 11:59 p.m. A registration not renewed by that deadline is considered expired and removed from the account, and FDA treats an expired registration as a failure to register, which is a prohibited act under FD&C section 301(dd) (21 CFR 1.241).
Two data checks now decide whether a renewal goes through. A Unique Facility Identifier has been mandatory since October 1, 2020 (1.232(a)(2)), and FDA accepts the DUNS number as that UFI. FDA verifies the UFI and checks that the address tied to the DUNS number matches the facility address in the registration; it will not confirm a new registration, or a renewal that updates the UFI, until the two agree (21 CFR 1.231(a)(3)). A plant that moved, merged or registered its DUNS under a head-office address will not clear until the records agree, and fixing a DUNS record takes time the supplier should not spend in the last week of December.
If nothing has changed since the last cycle, the facility can file an abbreviated renewal (1.230(c)). Registration data is exempt from public disclosure (1.243), so there is no public database where an importer can look up a supplier’s number. The importer has to ask for it, and after January 1, 2027 has to ask again to confirm it was renewed.
- October 2026: request each food supplier’s renewal plan and DUNS details.
- November 2026: confirm renewals filed; chase any address mismatch.
- Before the first sailing that arrives after January 1, 2027: collect written confirmation of the renewed registration.
Fees and the Annual Device Registration Cycle
Food, cosmetic and electronic product registrations carry no FDA registration fee, and drug registration itself has none. Medical devices are the exception. Under FR Doc. 2026-15335, published July 30, 2026, the FY2027 establishment registration fee is $13,785 per establishment, covering payments from October 1, 2026 to September 30, 2027. The fee is paid first, since FDA will not accept the registration until the payment is processed (FD&C section 738(f)(2)), and the annual registration itself falls between October 1 and December 31, 2026 (21 CFR 807.22(b)).
There is no small-business discount on the establishment fee. FDA may, but is not required to, waive the annual fee (not the initial one) for a qualifying small business. The fee applies per establishment, so a foreign group with three plants shipping devices to the US pays for each registered site, and the same applies to US specification developers and initial importers that must register.
Missing the annual cycle puts the establishment in failed-to-register status, and it is not considered active (807.22(c)). Listing carries no separate fee, but the listing must match what is declared at entry: the foreign manufacturer’s registration number goes out as the DEV Affirmation of Compliance, the foreign exporter’s as DFE, and the listing number as LST. FDA says entries with complete, accurate and valid data may receive a lower risk score and release without further review, so codes that do not match the FURLS record work directly against the shipment.
What Happens at the Port When Registration Is Missing
Since August 4, 2025, FDA reviews entries that do not clear automatically through the national FDA ImportShield Program rather than port by port. Registration data is part of that screen, and the consequences of a gap differ sharply by product.
Food: held at the port, no bond release
Under FD&C section 801(l), food from an unregistered or suspended foreign facility is held at the port of entry and may not be delivered to the importer, owner or consignee until the facility registers. Release under bond is not available. Under 21 CFR 1.285 the goods become general order merchandise, stay within the port unless CBP or FDA directs otherwise, and move only under custodial bond to a location FDA has been notified of, at the port or at a secure facility. The foreign facility has 30 calendar days from the hold notice to register and send the number to FDA; after that, the goods are handled under 19 CFR part 127 and may only be sold for export or destroyed. Neither FDA nor CBP pays for storage (1.285(e)), so every day of the 30 lands on the importer.
Devices: no listing, no import
21 CFR 807.40(c) bars import of any device that is not listed or not made at a registered foreign establishment, with an exception for investigational devices under part 812. Section 801(o) allows FDA to refuse admission when the entry does not identify the registration of each establishment required to register. Firms without valid drug or device registration or listing are also placed on Import Alert 99-34, which subjects their shipments to detention without physical examination.
Drugs and cosmetics
For drugs, FDA states that a detention can follow when the declared manufacturer cannot be found in its drug registration database. FDA’s March 10, 2026 Quick Reference Guide makes the REG and DLS codes mandatory for over-the-counter drugs and for APIs intended for further processing, and the DA code mandatory for prescription products under an NDA, ANDA or BLA. For cosmetics, the same guide still lists the COS registration number as optional at entry. MoCRA registration is a legal obligation, but not yet a mandatory ACE data element; sending it anyway helps FDA match the firm.
A Registration Check Before the Purchase Order Ships
Registration failures are cheap to prevent and expensive to fix after arrival, because the clock and the storage bill both start at the port. The check belongs at supplier onboarding and again before each renewal window, not when the arrival notice comes in. It sits alongside the other admissibility screens covered in our overview of restricted imports into the US.
A broker cannot pull a food registration from a public source, so the check depends on documents the supplier provides and on the data sent to FDA matching them. Our customs brokerage team transmits the FDA message set with the registration, listing and identifier codes each product requires. Registration status also belongs in the supplier file of any trade compliance management program, with renewal dates attached, so a lapse shows up as a task in October rather than a hold notice in January.
- Food: registration number, DUNS number and the address tied to it, US Agent name and physical address, renewal confirmation for the 2026 cycle.
- Devices: foreign manufacturer and exporter registration numbers, listing number, premarket number where one applies, FY2027 fee paid and registration active after December 31, 2026.
- Drugs: registration and listing in FDA’s database under the exact manufacturer name and address on the invoice.
- Cosmetics: facility registration number and the date its 2-year cycle renews, plus product listing for every SKU.
- Electronics: accession number for each product report and the name of the agent for service of process.
Frequently Asked Questions
Is 2026 a food facility registration renewal year?
Yes. Food facilities renew in even-numbered years, and FDA’s user guide sets the 2026 window from October 1, 2026 at 12:01 a.m. to December 31, 2026 at 11:59 p.m. A registration not renewed by then is considered expired and removed.
Does FDA charge a fee for food facility registration?
No. 21 CFR 1 subpart H sets no registration fee. Of the regimes covered here, only medical device establishments pay an annual registration fee, which is $13,785 per establishment for FY2027.
Is a DUNS number required for FDA food facility registration?
A Unique Facility Identifier has been mandatory since October 1, 2020, and FDA accepts the DUNS number as that identifier. FDA checks that the DUNS address matches the facility address before it confirms a renewal.
Can a customs broker act as the FDA US Agent?
The rules require a person who resides or keeps a place of business in the United States and, for food and drugs, is physically present there. Whether a broker takes the role is a commercial decision, and the agent receives FDA communications that bind the foreign firm.
Our supplier relabels in a third country. Does the original plant still need to register?
Yes. The foreign facility exemption applies only when another foreign facility further processes or packages the food, and it does not cover labeling or similar de minimis activity (21 CFR 1.226(a)).
What happens if a supplier's food registration lapses?
Its shipments are held at the port under FD&C section 801(l) with no bond release. The facility has 30 calendar days from the hold notice to register and send the number to FDA, and the importer bears storage costs in the meantime.
Do cosmetic facilities renew on a fixed date like food facilities?
No. Under MoCRA a cosmetic facility renews every 2 years from its own initial registration date, while product listings are updated annually.
