FDA Registration Support for Importers
Who actually registers, what your importer-specific duties are by product, and how to keep shipments clearing customs.
Key Takeaways
- The foreign facility registers — not usually the importer (+ it needs a U.S. Agent).
- Food importers — run an FSVP and file Prior Notice for each shipment.
- Device importers — the "initial importer" must register & list (the exception).
- Drug/cosmetic importers — rely on the foreign facility's registration + entry compliance.
- All imports — entry filing, and import-alert/DWPE risk if something's off.
- Registration/FSVP ≠ FDA approval.
Who Actually Registers — You or Your Supplier?
This is where importers most often get confused. In most cases:
- Your foreign supplier/manufacturer registers its establishment with FDA — and, being foreign, designates a U.S. Agent
- You, the U.S. importer, generally don't register a facility just to import — unless you also manufacture, process, pack, or hold the product
- The exception is devices: the "initial importer" of a device must itself register and list with FDA
- Your job is importer compliance — verification, notice, entry — plus confirming the foreign facility actually did register
Importer Duties by Product Type
| You import… | Foreign facility | Your importer duties |
|---|---|---|
| Food / supplements | Must be FDA-registered | FSVP (21 CFR 1 Subpart L) + Prior Notice each shipment; DUNS for FSVP |
| Medical devices | Registered + listed + U.S. Agent + clearance/approval | Initial importer registers & lists (21 CFR 807) |
| Drugs (OTC/Rx) | Registered + listed + U.S. Agent; proper product status | Entry compliance (importer generally not a registered establishment) |
| Cosmetics | MoCRA facility registration + product listing | Entry compliance |
What "Registration Support for Importers" Covers
- Foreign facility — confirm (or complete) its FDA registration and U.S. Agent
- Food — set up FSVP and Prior Notice; your DUNS as FSVP importer
- Devices — register and list you as the initial importer
- Drugs/cosmetics — confirm foreign registration and get entry compliance right
- Product compliance — labeling, claims, and any required clearance/approval
- Risk reduction — head off import-alert/DWPE problems before they start
Common Importer Registration Mistakes
- Assuming you must register as a facility when it's the foreign supplier's job
- Not confirming the foreign facility is registered with a current U.S. Agent
- Missing FSVP or Prior Notice for food
- Not registering as the initial importer for devices
- A DUNS mismatch; importing a product that lacks required clearance/approval
- Treating registration/FSVP as "FDA approval"
Get Import Registration Support
FDA Registration Assistance maps your import chain and sets up the right pieces — confirming or completing the foreign facility's registration and U.S. Agent, your importer-specific requirements (FSVP and Prior Notice for food, initial-importer registration for devices, entry compliance for drugs/cosmetics), product compliance, and steps to reduce import-alert/DWPE risk — across every category you import.
Contact us at info@fdaregistrationassistance.com or call +1 (928) 275-8333 for a quote. An independent compliance firm serving 1,000+ companies across 135+ countries, with 15+ years of experience.
Frequently Asked Questions — Registration Support for Importers
1. As an importer, do I have to register with FDA?
Usually not the way people expect. Establishment registration is generally the foreign manufacturer/facility's obligation - it registers with FDA and designates a U.S. Agent. As the importer, you typically don't register as a facility (unless you also manufacture, process, pack, or hold the product). Instead, you have importer-specific obligations that vary by product - like FSVP and Prior Notice for food, or initial-importer registration for devices. So "registration support for importers" is really about getting the right combination of foreign-facility registration and your own importer duties in place.
2. Who actually registers — me or my foreign supplier?
In most cases, your foreign supplier/manufacturer registers its establishment with FDA (and needs a U.S. Agent because it's foreign). You, the U.S. importer, generally don't register a facility for simply importing. The main exception is medical devices: the "initial importer" of a device must itself register and list with FDA. Outside that, your role is importer compliance (verification, notice, entry) rather than facility registration. Confirming who registers - and making sure the foreign facility actually did - is step one.
3. What are a food importer's FDA obligations?
Two big ones. First, FSVP (Foreign Supplier Verification Program, 21 CFR 1 Subpart L): as the U.S. importer you must verify that your foreign supplier produces food meeting U.S. safety standards - with a documented program, and you need a DUNS number identified in your entry (the FSVP importer field). Second, Prior Notice: FDA must receive advance notice of each food shipment before it arrives. On top of that, your foreign supplier's facility must be FDA-registered. See our FSVP and food importer pages for the detail.
4. What are a medical device importer's obligations?
Devices are the exception where the importer registers. The "initial importer" - the first U.S. party that receives an imported device - must register and list with FDA under 21 CFR Part 807. Separately, the foreign manufacturer must also be registered and listed and have a U.S. Agent, and the device must have any required clearance/approval (510(k)/PMA). So a device import chain often has two registered parties: the foreign manufacturer and the U.S. initial importer.
5. What about drug and cosmetic importers?
For drugs, the foreign drug establishment registers and lists (with a U.S. Agent), the product needs its proper status (approval/monograph compliance), and you file the import entry - the importer generally isn't a registered "establishment" just for importing. For cosmetics under MoCRA, the foreign facility registers and products are listed; the importer handles entry. In both, the pattern is the same as food/devices: confirm the foreign facility's registration is in place, meet any importer/entry duties, and ensure the product itself is compliant.
6. What is Prior Notice and do all importers need it?
Prior Notice is FDA's requirement to be notified in advance of imported food shipments (human and animal food), so FDA can review them before arrival. It's specific to food - each shipment needs Prior Notice submitted within FDA's timeframes, or the shipment can be refused/held. It's separate from registration and from FSVP. Non-food imports (drugs, devices, cosmetics) have their own entry requirements but not "Prior Notice" in this food-specific sense.
7. Does my foreign supplier need a U.S. Agent?
Yes - any foreign establishment that registers with FDA must designate a U.S. Agent, and its registration generally can't be completed without one. As an importer, it's in your interest to confirm your foreign supplier has a valid, current U.S. Agent and an active registration, because gaps there can hold your shipments at the border. Many importers ask their supplier to confirm this, or arrange U.S. Agent service to keep the supply chain moving.
8. What does "registration support for importers" actually include?
Practically: (1) confirming the foreign facility is properly registered and has a U.S. Agent; (2) setting up your importer-specific requirements - FSVP and Prior Notice for food, initial-importer registration/listing for devices, and the correct entry compliance for drugs/cosmetics; (3) making sure the product itself is compliant (labeling, claims, any required clearance/approval); and (4) reducing import-alert/detention risk. It's coordinating the foreign-side registration and your importer duties so entries clear.
9. Can non-compliance get my shipments stopped?
Yes. If the foreign facility isn't registered, the U.S. Agent is missing/outdated, FSVP or Prior Notice is deficient (food), the initial importer isn't registered (devices), or the product is misbranded/adulterated, shipments can be detained or refused at the border. Repeated or serious problems can lead to an import alert and Detention Without Physical Examination (DWPE), where matching shipments are held automatically. Getting the registration and importer duties right up front is how you avoid this.
10. I import products in more than one category — what then?
Each category follows its own rules. A company importing, say, a food, an OTC drug, and a device would deal with: FSVP + Prior Notice + registered foreign food facility (food); registered foreign drug establishment + entry (drug); and initial-importer registration + registered foreign manufacturer + device clearance (device). The obligations don't merge - but one provider can coordinate all of them, keeping the foreign registrations, U.S. Agents, and your importer duties aligned across categories.
11. Do I need a DUNS number as an importer?
For food, yes - the FSVP importer must be identified at entry with a DUNS number (the Unique Facility Identifier), so you'll need a DUNS for your importing entity. DUNS numbers are issued free by Dun & Bradstreet. Foreign facilities also need a DUNS as their UFI for registration. So DUNS shows up in two places in a food import: your foreign supplier's registration, and your FSVP importer identification. Get them right and matching.
12. Is registering (or FSVP) the same as FDA approval?
No. Facility registration, FSVP, Prior Notice, and initial-importer registration are all administrative/compliance steps - none of them means FDA reviewed or approved your product. Approval/clearance (where it applies, like a device 510(k) or a drug approval) is separate. So don't market an imported product as "FDA approved" because the facility is registered or you have an FSVP program - describe it accurately, and make sure any product that needs premarket authorization actually has it.
13. What's the difference from your food importer and FSVP pages?
This page is the cross-product importer overview - who registers, and what importer duties apply for food, drugs, devices, and cosmetics. For the food-specific detail, see our food importer registration page and our FSVP for importers guide. For the underlying registration concept, see FDA establishment registration; for the foreign facility's U.S. Agent, see the U.S. Agents hub. Start here to see the whole picture, then go deep on your product.
14. When should I sort this out — before I import?
Before your first shipment. Confirm the foreign facility is registered with a valid U.S. Agent, set up FSVP and Prior Notice (food) or initial-importer registration (devices), verify the product is compliant, and get your DUNS in place - all before goods are en route. Sorting it out at the border is expensive: a missing registration, a deficient FSVP, or a late Prior Notice can hold or refuse the shipment. Lead time on registration and DUNS is the reason to start early.
15. What are the most common importer registration mistakes?
Assuming you (the importer) must register as a facility when it's really the foreign supplier's job; not confirming the foreign facility is actually registered with a current U.S. Agent; missing FSVP or Prior Notice for food; not registering as the initial importer for devices; a DUNS mismatch; importing a product that needs clearance/approval it doesn't have; and treating registration/FSVP as "FDA approval." Most trace back to confusion over who is responsible for what in the import chain.
16. How does FDA Registration Assistance support importers?
We map your import chain and set up the right pieces: confirming (or completing) the foreign facility's registration and U.S. Agent, your importer-specific requirements (FSVP and Prior Notice for food, initial-importer registration for devices, entry compliance for drugs/cosmetics), product compliance (labeling/claims/clearance), and steps to reduce import-alert/DWPE risk - coordinated across every category you import. We're an independent compliance firm serving 1,000+ companies across 135+ countries with 15+ years of experience. Contact info@fdaregistrationassistance.com or +1 (928) 275-8333.
