FDA Registration Services for Food, Drug, Medical Device and Cosmetics

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Medical Device

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Drugs

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Cosmetics

	Food / Supplements	Medical Devices	Drugs	Cosmetics (MoCRA)
Registration Required?	YES — Foreign + Dom	YES — Foreign	YES — Foreign + Dom	YES (MoCRA, Jul 2024)
US Agent Required?	YES (foreign only)	YES (foreign only)	YES (foreign only)	YES (foreign only)
Renewal frequency	Every 2 years (Oct 1 – Dec 31, even years)	Annual (Oct 1 – Dec 31, every year)	Annual (Oct 1 – Dec 31, every year)	Every 2 years (facility); annually (product listing)
FDA Gov Fee for Registration	Free (no FDA fee)	MDUFA $11,423/yr for 2026*	GDUFA, OMUFA, PDUFA may apply**	Free (no FDA fee)
Consequence of Non-Compliance	Shipments detained at US border; registration cancelled; prohibited act under FD&C Act	Inactive registration; cannot import or submit new device applications to FDA	Inactive status; drug listings removed from NDC directory; misbranding violations	Violations subject to FDA enforcement; products may be considered misbranded
Timeline	1–2 days***	3–5 days***	1–2 days***	1–2 days***

*Medical device FY2026 fee is $11,423. Small businesses with $1M or less in gross sales may qualify for a hardship waiver on renewals. See: fdabasics.com/fda-medical-device-registration-fee-and-waiver-guide/

**See our free guide on all Drug User Fees here: https://www.fdabasics.com/fda-drug-user-fees-reference-guide/

***Registration may take longer if you do not have a DUNS, FEI Number or have issues with Fee payments to the FDA.

Food and Dietary Supplements

Foreign food manufacturers, dietary supplement producers, and food importers must register their facility with the FDA under the Food Safety Modernization Act (FSMA) and designate a US FDA Agent before their first shipment enters the United States. Registration must be renewed every two years between October 1 and December 31 of each even-numbered year. There is no government fee for food facility registration. See our full Food and Dietary Supplement Registration page for compliance requirements, renewal deadlines, FSVP information, and our services and fees.

Medical Devices

Foreign medical device manufacturers must register their establishment with the FDA annually, list every device distributed in the US, designate a US FDA Agent, and pay the annual MDUFA Establishment Registration Fee — currently $11,423 for FY2026 — paid directly to the FDA between October 1 and December 31 each year. Device classification determines whether a 510(k) or PMA submission is also required. See our full Medical Device Registration page for the complete compliance checklist, FDA fee history, and our services.

Drugs

Foreign and domestic drug manufacturers must register their establishment with the FDA annually, obtain an NDC Labeler Code, and list every drug product in SPL format. Generic drug manufacturers with approved ANDAs also pay annual GDUFA facility fees that can exceed $250,000 per year for foreign facilities. Drug establishment registration and drug listing certification must both be renewed every year between October 1 and December 31. See our full Drug Registration page for OTC, generic, prescription, and API manufacturer requirements.

Cosmetics (MoCRA)

Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), all foreign cosmetic manufacturers must now register their facility with the FDA, designate a US FDA Agent, and submit a product listing for every cosmetic product distributed in the United States. Compliance with MoCRA facility registration was required by July 1, 2024. There are no government fees for cosmetic registration or product listing. See our full MoCRA Cosmetic Registration page for the complete requirements, renewal dates, and our services.

What information is required for FDA registration?

Not much. You will need your company name and address, facility address and activity type (manufacturing, packaging, storage, etc.), and basic product information for your industry. Foreign companies also need a US FDA Agent — when you register through FDABasics, we handle that automatically.

The forms are manageable. Where companies run into trouble is knowing which registration applies to their products, selecting the correct establishment activities, and staying on top of renewals as requirements change. A mistake can cause real problems at the US border.

FDABasics has handled registrations for companies in 50+ countries for over 30 years. We make sure it is done right — and stays right.

Ready to get started? Complete the short form on our website and we will take it from here.

What is the difference between FDA registration and FDA approval? Here's what you need to know.

FDA registration and FDA approval are two different requirements and are often confused. FDA registration means your facility is listed with the FDA as a manufacturer, processor, packer, or holder of a regulated product. FDA approval means the FDA has reviewed the safety, efficacy, or equivalency data for a specific product before it can be marketed.

For most food, dietary supplement, and OTC drug products, FDA approval is not required — but you must still comply with general requirements such as food safety regulations, labeling rules, and current Good Manufacturing Practice (cGMP) standards. Most Class I medical devices are also exempt from premarket approval.

FDA approval is required before marketing prescription drugs (via NDA or ANDA), Class II and Class III medical devices (via 510(k) clearance or PMA), and food additives. Cosmetic products do not require FDA approval, but must comply with safety and labeling requirements and are now subject to facility registration and product listing under MoCRA.

If you have any questions about FDA registration or whether your product requires FDA approval, contact us.

Why Choose FDABasics?

FDABasics has been helping foreign manufacturers navigate US FDA requirements since 1995, with over 30 years of regulatory experience serving clients across the food, drug, medical device, and cosmetics industries. We are headquartered in New York, USA and combine deep expertise with the most competitive fees in the industry.

30+ Years of Experience

Originally founded in 1995 as Tobias Systems, we have guided thousands of foreign companies through FDA registration, US Agent services, and full compliance across all four regulated industries.

5-Star Rated on Trustpilot and Google

Our clients consistently rate us 5 stars on both Trustpilot and Google for fast turnaround times, clear communication, and expert handling of their FDA compliance needs.

Strict Client Confidentiality

We believe in ethical business practices and maintain strict confidentiality for all clients. We do not share your information and we do not offer advice simply to sell services.

Lowest Fees, No Hidden Charges

Our fees are straightforward with no hidden charges. We guarantee a cost-effective solution for your business, whether you are a startup or an established manufacturer.

Fast Turnaround and Responsive Service

We know that FDA registration issues can hold up your shipments and delay your market entry. We work quickly and respond promptly so that your compliance is never a bottleneck for your business.

Global Clients, US-Based Team

We serve manufacturers from over 100+ countries and are physically located in the United States, which is a legal requirement for any company serving as your official US FDA Agent.

Get Started on your Registration Today!

Foreign Food Facility

Domestic Food Facility

Medical Device

Drug Establishment

Cosmetics (MoCRA)