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US FDA Registration Consultation

Expanding your business into the United States? Then, securing US FDA Registration is not just a regulatory requirement—it’s a critical step to ensure product acceptance, brand trust, and long-term success in one of the world’s most competitive markets.

EVTL India, a leading global compliance consultancy, offers end-to-end US FDA registration consultation services to help manufacturers and exporters navigate the complex regulatory landscape with confidence and ease.

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Home Testing US FDA Registration Consultation

Overview
What is US FDA Registration?
Why Choose EVTL India for US FDA Registration?
Process
What Makes FDA Registration with EVTL India Different?
Key Benefits of FDA Registration
Work with EVTL India – Your One-Stop FDA Compliance Partner
Frequently Asked Question (FAQ)

What is US FDA Registration? - Overview

The U.S. Food and Drug Administration (FDA) mandates registration for every company that manufactures, processes, packs, or stores food, drugs, cosmetics, or medical devices intended for the U.S. market. This registration ensures your products meet FDA’s stringent quality, safety, and labeling standards.

Without this registration, your goods can be:

Detained at U.S. ports
Returned to the country of origin
Rejected by importers or distributors
Subjected to legal action or fines

Why Choose EVTL India for US FDA Registration?

With vast experience in global regulatory compliance, EVTL India is your trusted partner for smooth and secure FDA compliance. Our local presence in countries including India, USA, UK, Germany, Australia, South Korea, Thailand, Taiwan, Malaysia, and Vietnam ensures on-ground support wherever you are.

By appointing EVTL India as your US FDA Agent, you benefit from:

A centralized point of contact, reducing dependency on multiple importers/distributors
End-to-end support from facility registration to label compliance
Continued compliance guidance, even as your partnerships change

Our Step-by-Step US FDA Registration Process

Step 1- Appoint a US FDA Agent & Register Your Facility: We help you appoint a reliable US Agent and initiate establishment registration, including DUNS number assistance.

Step 2- Identify Product Classification: Our experts analyze whether your product falls under FDA regulation and determine its applicable product code and regulatory pathway.

Step 3- Label & Packaging Review: Labeling is a critical component of FDA compliance. We ensure your packaging aligns with FDA standards for cosmetics, drugs, devices, or food items.

Step 4- Ensure Good Manufacturing Practices (GMP): We help you align your manufacturing process with FDA GMP guidelines—essential for product safety and successful audits.

Step 5- Submit & Secure FDA Registration Number: After complete documentation and facility details submission, we follow up with the FDA to obtain your official registration number.

What Makes FDA Registration with EVTL India Different?

Global Support: Offices across multiple continents ensure localized communication and faster response.
Expert Guidance: Regulatory professionals with years of hands-on experience in FDA submissions.
Transparency: Clear communication, realistic timelines, and compliance-first strategies.
Cost-Efficient Packages: Flexible pricing for startups, MSMEs, and large exporters alike.

Key Benefits of FDA Registration

Entry into the US market

Boosted brand credibility and trust

Reduced risk of import delays or penalties

Improved product quality and traceability

Eligibility for export to other regulated markets

Work with EVTL India – Your One-Stop FDA Compliance Partner

Whether you are a manufacturer of dietary supplements, medical devices, packaged foods, or cosmetics, EVTL India is here to guide you from start to finish. We simplify the regulatory process so you can focus on your core business—growth and innovation.

Let EVTL India be your reliable partner for seamless US FDA registration and consultation.

Contact us today to schedule your first consultation and start your journey toward compliant and profitable exports to the USA!

Frequently Asked Questions (FAQ)

What is US FDA Registration?

US FDA Registration is the process by which manufacturers, exporters, and importers of food, drugs, medical devices, and cosmetics register their facilities with the United States Food and Drug Administration (FDA) in compliance with federal regulations.

Who needs to register with the US FDA?

Companies that manufacture, process, pack, or store products regulated by the FDA—such as food, dietary supplements, medical devices, drugs, and cosmetics—intended for the U.S. market must register.

Is US FDA Registration mandatory?

Yes, for most regulated products, FDA registration is legally required before products can be marketed, imported, or sold in the U.S. Failure to register can lead to shipment rejections and legal penalties.

Does FDA provide a registration certificate?

No, the FDA does not issue a registration certificate. However, you can obtain a registration confirmation or a certificate of registration through a third-party FDA agent or consultant, which is often used for business or marketing purposes.

How long does the FDA registration process take?

FDA registration can typically be completed within 1–5 business days, depending on the product category and availability of required information.

How long is FDA registration valid?

FDA registration must be renewed annually between October 1 and December 31 for food and drug facilities. If not renewed, the registration will be considered expired and canceled.

What information is required for FDA registration?

Basic details include facility name and address, product categories, owner/operator information, and a U.S. Agent (for foreign facilities). Device and drug registrations may require additional product listings and labeling information.

What is a US FDA Agent and is it required?

Yes, foreign companies must appoint a U.S. FDA Agent who acts as a point of contact between the FDA and the company. The agent must be located in the U.S. and respond to FDA communications.

What is FDA product listing?

In addition to registering your facility, certain products (like drugs and medical devices) must be listed with the FDA, providing detailed information about the product and its intended use.

Does FDA registration mean FDA approval?

No. FDA registration is not the same as FDA approval. Registration simply informs the FDA of your business and products. FDA approval involves a formal evaluation process (e.g., for new drugs or Class III medical devices).