US FDA Registration / Compliance

Register with the FDA and stay compliant to sell into the US market

The US Food and Drug Administration (FDA) regulates food, drugs, medical devices, cosmetics, dietary supplements, and tobacco products sold in the United States. Depending on your product category, this means facility registration, product listing, premarket submissions, and ongoing compliance with FDA’s manufacturing and labelling requirements — administered under agencies within FDA such as CFSAN (food), CDER (drugs), and CDRH (medical devices).

We help you determine exactly which FDA pathway applies to your product, manage registration and submissions, and set up the compliance systems FDA expects to see maintained.

Which pathway applies to you?

	Food Facility Registration	Medical Device (510(k)/PMA)	Drug (NDA/ANDA/OTC Monograph)	Cosmetics (MoCRA)
Applies to	Food/beverage manufacturers, processors, packers, storage facilities	Medical device manufacturers	Drug manufacturers (prescription, generic, OTC)	Cosmetic product manufacturers/marketers
Requirement	Biennial facility registration + Prior Notice for imports	Premarket clearance (510(k)) or approval (PMA), based on device risk class	New Drug Application, Abbreviated NDA (generics), or OTC monograph compliance	Facility registration + product listing (mandatory since MoCRA)
Governing framework	FSMA (Food Safety Modernization Act)	FD&C Act, device classification (Class I/II/III)	FD&C Act	Modernization of Cosmetics Regulation Act, 2022
US Agent required?	Yes, for foreign facilities	Yes, for foreign manufacturers	Yes, for foreign manufacturers	Yes, for foreign facilities

Who needs this: foreign and domestic food manufacturers/exporters, medical device manufacturers, drug manufacturers (including generics and OTC), dietary supplement companies, and cosmetics manufacturers/marketers selling in the US.

Typical timeline: Food facility registration — 1–2 weeks. 510(k) medical device clearance — 3–9 months depending on device class and FDA review cycles. Drug approvals (NDA/ANDA) — can run 10 months to several years depending on pathway and review designation.

Process

Step 1 — Product classification and pathway determination
We identify how FDA classifies your product — food, drug, device (and device risk class), cosmetic, or dietary supplement — since this determines every subsequent requirement.

Step 2 — US Agent appointment
Foreign facilities and manufacturers are required to designate a US Agent — a US-based point of contact for FDA communications. We can act in this capacity or coordinate with your appointed agent.

Step 3 — Facility registration

Food facilities: Registered via FDA’s FURLS system, renewed every two years (Oct–Dec even years), including Foreign Supplier Verification Program (FSVP) compliance for importers
Medical devices: Establishment Registration and Device Listing via FDA’s FURLS/DRLM system
Drugs: Facility registration and product listing via FDA’s electronic system
Cosmetics (MoCRA): Facility registration and product listing, now mandatory for most cosmetic manufacturers

Step 4 — Premarket submission (where applicable)

Medical devices: 510(k) premarket notification (demonstrating substantial equivalence to a predicate device) or PMA (Premarket Approval, for higher-risk Class III devices)
Drugs: NDA for new drugs, ANDA for generics, or OTC monograph compliance for eligible over-the-counter products
Food: Prior Notice filing required for each import shipment; new dietary ingredients require notification

Step 5 — Testing and technical documentation
Product testing, clinical or bioequivalence data (for drugs/devices), labelling review, and Good Manufacturing Practice (GMP/cGMP) documentation are compiled to support the registration or submission.

Step 6 — Labelling compliance review
US labelling requirements — nutrition facts, ingredient declarations, allergen labelling, device labelling, or drug facts panels — are reviewed against FDA regulations, which differ meaningfully from other markets’ labelling norms.

Step 7 — Submission and FDA review
Applications are filed through the relevant FDA electronic system; for premarket submissions, this includes responding to FDA information requests (Additional Information letters) during review.

Step 8 — Post-registration compliance
Ongoing obligations include biennial renewal (food facilities), adverse event reporting, facility inspection readiness, and updates for any product or process changes that affect the original submission.

Documents & Information Required

About the company/facility

Business registration details
Facility address and DUNS number
US Agent appointment details (mandatory for foreign facilities)
Facility layout and process description

About the product

Complete product formulation/composition or device specifications
Labelling artwork (packaging, inserts, nutrition/drug facts panels)
Intended use and target population/claims made
Existing test reports or certifications from other markets, if available

For food facilities

HACCP plan or Food Safety Plan (as required under FSMA)
Foreign Supplier Verification Program documentation (for importers)
Ingredient and allergen list

For medical devices

Device classification rationale and predicate device comparison (for 510(k))
Clinical/performance test data
Quality System (QSR/ISO 13485) documentation
Risk analysis documentation

For drugs

Manufacturing process and cGMP compliance documentation
Stability and bioequivalence data (for ANDAs)
Clinical trial data, where applicable (NDA pathway)

For cosmetics (MoCRA)

Product listing with ingredient information
Safety substantiation documentation
Adverse event reporting contact details

Notes

A US Agent is a regulatory requirement, not optional, for any foreign facility or manufacturer in these categories.
Registration alone does not mean FDA has “approved” a food facility or cosmetic product — this distinction matters for how compliance can be described in marketing.

Benefits

Legal market access
For regulated categories, FDA registration/clearance/approval is a legal precondition for selling in the US — without it, products can be detained at the border, refused entry, or subject to warning letters and seizure.

Avoids import detentions and delays
A registered facility and properly filed Prior Notice (for food) significantly reduce the risk of shipments being held at US ports of entry, a common and costly failure point for exporters.

Builds credibility with US distributors and retailers
US distributors, retailers, and healthcare institutions routinely require proof of FDA registration or clearance before agreeing to carry or purchase a product.

Reduces enforcement and liability risk
Proper registration, labelling, and GMP compliance substantially lower the risk of FDA warning letters, import alerts, recalls, and associated liability exposure.

Structured quality and safety systems
The documentation and process rigor FDA expects — GMP, HACCP, Quality System Regulation — often improves manufacturing consistency and traceability well beyond what’s strictly required for compliance.

Positions for long-term US growth
Once foundational registration and compliance systems are in place, expanding your product line or adding new US customers becomes significantly faster, since the regulatory infrastructure already exists.

Global credibility signal
FDA compliance is widely recognised internationally as a rigorous regulatory bar, and can support credibility conversations in other markets even outside the US.