FDA Registration Requirements Made Easy
Expanding into the United States? The U.S. Food and Drug Administration (FDA) requires thousands of companies each year to register before selling their products in the world’s most competitive market. At USAgentPros, we make FDA registration simple, fast, and worry-free — so you can focus on growing your business.
Do You Need FDA Registration?
If your company produces or distributes products in the categories below, FDA registration may be required:
- Food & Beverage (Including dietary supplements and animal food)
- Medical devices
- Drug products (including OTC)
- Tobacco products
- Radiation-emitting devices (RED)
- Biologics
Each category has specific rules and exemptions. Our compliance experts help you determine exactly what applies to your business, avoiding costly mistakes and delays.
For example, food and dietary supplement facilities must be registered **before shipping products into the U.S.** and renew every even-numbered year between October 1 and December 31.
Why FDA Registration Matters
Registering your facility with FDA:
- Promotes consumer safety
- Keeps your business legally compliant
- Reduces the risk of shipment delays, detentions, or rejections
FDA registration typically requires detailed information on your facility, processes, quality controls, labeling, recall procedures, and more. We guide you through every step — without the stress.
Dietary Supplement Facility Registration
Dietary supplements are regulated as part of the food industry, meaning manufacturers, processors, packagers, and warehouses must register their facilities with FDA to ship into the U.S.
Our services for dietary supplement facilities include:
- FDA Registration and Renewal assistance
- DUNS number support
- 24/7 U.S. Agent representation
- Prior Notice filing
- FDA Registration and Renewal assistance
- DUNS number assistance
- 24/7 U.S. Agent representation
- Prior Notice filing
Drug Facility Registration
All companies that manufacture, prepare, or distribute drug products for U.S. commercial sale must register with FDA. Registration must be completed **before shipment** and renewed annually (October 1–December 31).
Drug establishments must also list every drug in U.S. commercial distribution at the time of renewal.
Our support includes:
- FDA Registration and Renewal assistance
- DUNS number support
- 24/7 U.S. Agent representation
Drug Master File (DMF) Submissions
A Drug Master File (DMF) is a confidential submission of proprietary product data to FDA and other global regulators. USAgentPros can help prepare and submit DMFs in the required eCTD format.
Common DMF content includes:
- Drug substances and finished products
- Packaging materials
- Excipients and preparation data
- Facility and quality control information
Other FDA Registrations We Support
Along with food, dietary supplements, drugs, medical devices, and cosmetics, we also help register:
- Radiation-emitting devices (RED)
- Tobacco products
- Biologics
Certificate of Registration
FDA does not issue Certificates of Registration — but many buyers, brokers, and importers will request proof. USAgentPros provides a trusted third-party Certificate of Registration confirming your valid FDA registration. This document helps you satisfy supply chain requests with confidence.
Verify Your FDA Registration
FDA registration numbers can become invalid without warning, leading to port delays and detentions. Common causes include:
- Missed renewal deadlines
- Outdated ownership or facility information
- U.S. Agent changes or refusals
We provide **free FDA registration verification** so you can confirm validity and avoid last-minute surprises.
Affirmation of Compliance (AofC)
When products arrive at U.S. ports, Affirmation of Compliance codes can speed up FDA entry review. While optional, providing these codes often helps your shipment clear faster. USAgentPros assists with selecting and using the right AofC codes to improve your chances of smooth entry.
Why Choose USAgentPros?
- Dedicated Compliance Pro: A real person guiding your project
- Fast Turnarounds: We move at the speed your business needs
- 100% Money-Back Guarantee: Confidence built into every service
- Competitive Pricing: Trusted expertise without inflated fees
