US FDA Registration & Compliance (Food, Drugs & Medical Devices)
Facility registration, US Agent appointment, Prior Notice filing, and 510(k) clearance for exporting to the United States.
Overview
The United States Food and Drug Administration (US FDA), an agency within the US Department of Health and Human Services, enforces the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Title 21 of the Code of Federal Regulations (21 CFR). Any manufacturing facility located outside the United States that produces, processes, packs, or holds food, beverages, dietary supplements, pharmaceuticals, active pharmaceutical ingredients (APIs), cosmetics, or medical devices intended for consumption or distribution in the US market must register its establishment with the US FDA. Furthermore, foreign facilities are legally required to designate a permanent US Agent residing in the United States to handle regulatory communications and inspection scheduling with the FDA. Shipments arriving at US ports without active FDA registration numbers, proper Prior Notice confirmations, or compliant 21 CFR nutrition and drug labels are immediately flagged by US Customs and Border Protection (CBP) and placed on "Import Alert" (detention without physical examination). JRC Legal provides complete regulatory advisory for Indian exporters entering the US market.
Scope of US FDA Registration Service
Detailed compliance and filing scope managed by JRC corporate experts.
Documents Required for US FDA Registration
Upload digital files during onboarding. No physical submissions needed.
Establishment Credentials
- Full legal name, physical address, and manufacturing facility coordinates
- Valid DUNS (Data Universal Numbering System) Number matching exact facility name and address
- Details of the appointed US Agent (Name, US physical address, phone, and email)
Product Information & 21 CFR Labeling
- Comprehensive product catalog with ingredients, chemical formulation, or medical device classifications
- High-resolution packaging label artwork conforming strictly to 21 CFR formatting mandates
- Food Safety Plan or Quality Management System (ISO 13485 / cGMP) documentation
Step-by-Step US FDA Registration Procedure
Our step-by-step advisory workflow.
Step 1: DUNS Number Procurement & Data Alignment
We procure or update your DUNS number with Dun & Bradstreet to ensure exact character-by-character alignment with FDA databases.
Step 2: US Agent Appointment & Electronic Profile Creation
We establish the official US Agent representation and set up user accounts on FDA Industry Systems (FIS).
Step 3: Facility Registration & Category Disclosure
We submit the electronic establishment registration (Food, Drug, or Medical Device) disclosing all manufacturing operations.
Step 4: Product Listing & US Agent Confirmation
The US Agent confirms representation electronically on the FDA portal, and individual product listings are submitted.
Step 5: Registration Number Issuance & Compliance Dossier
The FDA generates the official Registration Number (and FEI Number), enabling immediate Prior Notice filing and shipment dispatches.
Strategic Benefits of US FDA Registration
Unlock export access to the world’s largest consumer economy without border detention risks.
Lawful Export Entry into the United States
Mandatory prerequisite to clear US Customs and Border Protection (CBP) and commercialize goods across all 50 US states.
Prevents Catastrophic Import Alerts & Port Holds
Avoids costly cargo detentions, container storage demurrage, and destruction orders at US ocean and air ports of entry.
Credibility with US Retailers & Wholesalers
US wholesale importers, Amazon.com US, and major retail chains strictly mandate verified FDA registration numbers before issuing purchase orders.
Compliance with Food Safety Modernization Act (FSMA)
Assists Indian food exporters in passing Foreign Supplier Verification Programs (FSVP) conducted by US food importers.
Global Gold Standard Brand Prestige
Operating in full compliance with US FDA regulations elevates brand reputation and investor confidence worldwide.
Frequently Asked Questions
Helpful answers to common regulatory inquiries.
Does the US FDA issue an official physical certificate of registration?▼
No. The US FDA does not issue paper registration certificates. Commercial "FDA Certificates" provided by consulting agencies are private verification documents for business credibility. Official registration is verified directly on the FDA’s online database via your unique Registration Number or FEI (FDA Establishment Identifier).
What is the role of a US Agent in FDA registration?▼
Under US law, every foreign facility must designate a permanent US Agent located within the United States. The US Agent acts as the primary liaison with the FDA, assists in scheduling FDA inspections of the foreign plant, and receives urgent regulatory notices and subpoenas.
When must Food Facility Registrations (FFR) be renewed with the US FDA?▼
Under the Food Safety Modernization Act (FSMA), food facilities must renew their FDA registration every two years (biennial renewal) between October 1 and December 31 of every even-numbered year.
What is an FDA DUNS Number and why is it mandatory?▼
The FDA mandates a Unique Facility Identifier (UFI) to confirm the physical location of manufacturing facilities. The Dun & Bradstreet DUNS number is currently the only recognized UFI. The facility name and address entered in the FDA registration must match the Dun & Bradstreet database with 100% precision.
What are the official government fees for US FDA registration?▼
The US FDA does not charge any government registration fee for Food Facilities (FFR). However, for Medical Device Establishments, the FDA levies an annual user fee (approximately USD 7,000 to USD 9,000 depending on the fiscal year). Drug establishments are subject to user fees under GDUFA / PDUFA where applicable.
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