US FDA Registration

What is US FDA Registration?

The U.S. Food and Drug Administration (FDA) requires all domestic and foreign facilities that manufacture, process, pack, or store food, drugs, medical devices, or cosmetics intended for consumption in the United States to be registered with the FDA. This mandatory registration is governed under the FDA Food Safety Modernization Act (FSMA) and Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

For Indian exporters targeting the US market, US FDA Registration is the essential first step before shipping any regulated product. Non-registered facilities face automatic detention or refusal of their shipments at US ports of entry, causing significant financial and reputational losses.

Mandatory Under FSMA & FD&C Act

All foreign food facilities exporting to the USA must be registered with US FDA and submit Prior Notice before each shipment.

U.S. Department of Health & Human Services

U.S. FOOD & DRUG
ADMINISTRATION

FDA - Silver Spring, MD, USA

Food Facility Registration Certificate

Under Section 415 of FD&C Act / FSMA

Registration No. 12345678901

Facility Name Sample Foods Pvt. Ltd.

Country India 🇮🇳

Product Category Human Food & Beverages

U.S. Agent I-NEXUS Consultants

Renewal Due Oct 1 – Dec 31, 2026

Who Needs US FDA Registration?

Any Indian business exporting food, drugs, medical devices, or cosmetics to the USA must register with US FDA before shipment.

Food & Beverage Exporters

Packaged food & snack manufacturers
Spices, condiments & masala exporters
Bakery & confectionery producers
Dairy & milk product manufacturers
Beverages, juices & health drinks
Seafood & aquatic product exporters
Dietary supplements & nutraceuticals
Infant formula & baby food companies

Applicable Law: FD&C Act Section 415 / FSMA

Pharma, Device & Cosmetic Exporters

Pharmaceutical drug manufacturers
API & bulk drug exporters
Medical device manufacturers
In-vitro diagnostic manufacturers
Cosmetics & personal care producers
Ayurvedic & herbal supplement firms
Animal food & veterinary drug exporters
Tobacco product manufacturers

Applicable Law: FD&C Act / 21 CFR Part 1 & 207

Types of US FDA Registrations

Food Facility Registration

Mandatory for all food facilities
Biennial renewal every even year
Requires U.S. Agent appointment
Prior Notice for each shipment
FSMA FSVP compliance required

Drug Establishment Registration

For pharma & API manufacturers
Annual renewal required
Drug Listing (NDC) required
cGMP compliance mandatory
FDA inspection eligibility

Medical Device Registration

510(k) premarket notification
PMA for Class III devices
Device listing with FDA
Quality System Regulation (QSR)
UDI labeling compliance

Cosmetics Facility Registration

Mandatory under MoCRA (2022)
Annual product listing required
Responsible person designation
Serious adverse event reporting
Safety substantiation required

Animal Food & Veterinary

Pet food facility registration
Veterinary drug approvals (NADA)
Animal food labeling compliance
FSMA Preventive Controls (Animal)
Medicated feed licensing

Dietary Supplement Registration

New Dietary Ingredient (NDI) notification
Good Manufacturing Practices (cGMP)
Adverse event reporting (AER)
Structure/function claims review
Label compliance review

Application Process

Eligibility Assessment

Identify product category and applicable FDA registration type

U.S. Agent Appointment

Appoint a U.S.-based FDA Agent to represent your facility

Document Preparation

Compile facility details, product lists, and compliance documentation

Online Registration (FURLS)

Submit registration on FDA Unified Registration & Listing System

FDA Confirmation

Receive Registration Number from FDA upon successful submission

Prior Notice & Shipment

File Prior Notice for each shipment before goods arrive at US port

Requirements & Benefits

Required Documents

Facility name, address & contact details
Name and address of U.S. Agent
Type of activity (manufacturing, packing, storage)
Complete list of food/drug product categories
Emergency contact information
Owner/operator name & business type
IEC (Import Export Code) of the company
FSSAI license (for food exporters)
GMP / ISO certifications (for pharma/devices)
Product labelling and ingredient details

Benefits of Registration

Legal authorization to export to USA market
Access to world's largest consumer economy
Prevention of shipment detention at US ports
Enhanced brand credibility & trust
Eligibility for US retail & e-commerce platforms
Compliance with FSMA regulations
Facilitates relationships with US importers & distributors
Improved export documentation record
Basis for obtaining US FDA Prior Notice approval
Opens doors to $4.5 trillion US healthcare market

Timeline & Investment

Processing Time

3–10 Working Days

For food facility registration

Government Fees

No Fee (Food)

Pharma/Device fees apply

Service Charges

₹15,000 – ₹60,000

Based on product type

Renewal Period

Every 2 Years

Oct 1 – Dec 31 of even years

Post-Registration Compliance

Prior Notice Filing

File Prior Notice before every shipment
Submit via FDA PNSI portal
Required at least 2 hours before arrival
Include shipment & facility details
Monitor FDA refusal/hold alerts

Biennial Renewal

Renew registration every even year
Window: Oct 1 – Dec 31
Cancellation if not renewed in time
Update facility or product changes
Maintain U.S. Agent appointment

FSMA Compliance

Preventive Controls plan (HARPC)
Foreign Supplier Verification Program
Sanitary Transport standards
Intentional Adulteration rule
Third-party audits as needed

FDA Inspections

Be prepared for FDA facility inspection
Maintain inspection-ready records
Respond to FDA Warning Letters promptly
Implement corrective action plans
Retain all compliance documentation

Why Choose I-NEXUS?

FDA Compliance Experts

Specialized team with deep knowledge of US FDA regulations, FSMA, and FD&C Act requirements

Fast Processing

Streamlined registration process with accurate document preparation ensuring quick approvals

U.S. Agent Services

We offer dedicated U.S. Agent appointment services required for all foreign FDA registrations

End-to-End Support

From initial registration to Prior Notice filing, renewal, and FSMA compliance — complete assistance