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First Auditors platform is a technology-driven platform that offers specialized legal and financial advisory services in India.

US FDA Registration

We specialize in US FDA Registration services to help your business meet compliance requirements and gain access to the US market. Our services include the following:

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01 Overview 02 Who Needs 03 Eligibility 04 Documents 05 Process 06 Authority & Fees 07 Validity 08 Rejection 09 How We Help 10 FAQ
Overview

US FDA Registration in India

One of the United States' bureaucratic governmental departments is the Department of Health and Human Services, which includes the Food and Drug Administration (FDA or USFDA). Companies delivering products from the United States are frequently requested to provide a "declaration" for products under the control of the Food and Drug Administration by distant clientele or foreign governments (FDA). A testimony is a report compiled by the FDA that includes information about the administrative or advertising status of an item.

The Food and Drug Administration (FDA), a division of the US Department of Health and Human Services, is headed by the US Commissioner of Food and Drugs. The United States President appoints the Commissioner with the advice and approval of the legislative body.

US FDA Registration Services in Chennai
Who Needs This Service

Is US FDA Registration the right fit for your business?

US FDA Registration is mandatory for any business involved in manufacturing, importing, or exporting products regulated by the FDA for the US market.

  • Pharmaceutical manufacturers
  • Food and beverage exporters
  • Medical device manufacturers
  • Cosmetics and personal care product exporters
  • Dietary supplement manufacturers
  • Tobacco product manufacturers
Eligibility Requirements

Who can apply for US FDA Registration

Eligible Business Entities
  • Sole proprietorship
  • Partnership firm
  • Limited Liability Partnership (LLP)
  • Private Limited Company
  • Public Limited Company
  • Importers and exporters
Key Requirements
  • Valid business registration in India
  • Active bank account in the name of the business
  • Registered business address in India
  • GST Registration (if applicable)
  • US Agent appointment (mandatory for foreign entities)
  • Product compliance with FDA regulations
Documents Required

Documents Required for US FDA Registration

Documents are grouped the way FDA reviews them — business details, registration proofs, and product information.

Business Documents
  • Business registration certificate
  • PAN Card of the business entity
  • GST Registration Certificate
  • Import Export Code (IEC)
Facility & Product Documents
  • Facility address and contact details
  • Product list with FDA product codes
  • Product specifications and formulations
  • Labeling and packaging information
US Agent Documents
  • US Agent appointment letter
  • US Agent contact information
  • FDA registration number (if previously registered)
  • DUNS number (if applicable)
Step-by-Step Procedure

US FDA Registration Process

Each stage is a real, sequential step through the US Food and Drug Administration registration process.

01
1–2 working days

Connect with First Auditor Team

Get in touch with our experts to discuss your US FDA registration requirements and product type.

02
2–3 working days

Document Collection & Verification

Submit all necessary documents for FDA registration. Our team verifies and completes the documentation.

03
1–2 working days

US Agent Appointment

Appoint a US Agent who will serve as the point of contact for FDA communications.

04
3–5 working days

FDA Online Registration

Submit the FDA registration application through the FDA Unified Registration and Listing System (FURLS).

05
2–3 working days

Product Listing

List all products with FDA using the appropriate product codes and submission methods.

06
5–10 working days

Application Processing by FDA

FDA processes the application and issues the FDA registration number and product listing confirmation.

07
1–3 working days

Certificate Issuance

Upon approval, we receive the FDA registration certificate and send a copy to you via email or courier.

Authority, Timeline & Fees

Where the application goes, and what it costs

Government Authority

US Food and Drug Administration (FDA), Department of Health and Human Services, United States Government.

Estimated Processing Period

Typically 15–30 working days from complete document submission, depending on FDA workload.

Certificate Issued

FDA Registration Certificate with unique registration number and product listing confirmation.

Fee Structure

Government fee varies based on registration type. Professional fee quoted upfront by First Auditor.

ComponentPaid ToNature of charge
FDA Registration Fee US FDA Varies based on facility and product type
US Agent Service Fee US Agent Annual fee for US Agent services
Professional fee First Auditor Quoted upfront, one-time

Government fees are prescribed by the US FDA. Our team quotes both components separately before you proceed, with nothing added later.

Validity & Renewal

How long is the US FDA Registration valid?

US FDA Registration is typically valid for a period of 1 year. To maintain the registration, businesses must:

  • Renew the registration annually between October 1 and December 31
  • Submit updated product listings if required
  • Maintain proper product records and documentation
  • Report any changes in business address or constitution
  • Comply with all FDA regulations and guidelines
  • Maintain quality standards for products
  • Keep US Agent information current
Common Reasons for Rejection

What causes FDA to reject an application

  • Incomplete or incorrect application form submission
  • Missing US Agent information or invalid US Agent
  • Invalid or expired business registration documents
  • Mismatch between product description and FDA product codes
  • Missing product listings for all products
  • Incomplete facility address details
  • Application submitted after the annual renewal deadline
  • Non-compliance with FDA quality standards
  • Missing DUNS number (if required for specific products)
How First Auditor Assists

One team, from document collection to certificate issuance

We manage every step, document, and follow-up with US FDA so you can focus on your business.

Eligibility & Document Check

We verify your eligibility and ensure all required documents are complete and valid.

Application Preparation

Complete application form drafting and verification to ensure error-free submission.

US Agent Appointment

Assistance in appointing a qualified US Agent for FDA communications.

Application Filing

Complete FDA registration application filing through the FURLS portal.

Query Handling

We respond to all queries from FDA on your behalf.

Compliance Calendar

A full compliance schedule including annual renewal reminders.

Dedicated Support

A single point of contact for questions throughout the entire process.

Frequently Asked Questions

FAQ

US FDA (United States Food and Drug Administration) Certification is an approval issued by the FDA to ensure that products such as food, drugs, medical devices, cosmetics, and dietary supplements meet the safety and quality standards required for sale and distribution in the United States.

The certification is crucial for gaining legal entry to the US market, assuring consumers and stakeholders about the safety, quality, and compliance of the product. It also enhances marketability and builds trust with buyers, helping businesses to compete globally.

Products that need FDA approval include human and animal medicines, medical biologics, medical devices, food (including animal), tobacco products, beauty items, and electronic items that produce radiation.

The timeline for registration depends on the product type and the complexity of regulatory requirements. It typically takes a few weeks to several months, depending on the readiness of the documentation and the outcome of facility inspections.

No, products regulated by the FDA cannot be marketed in the US without registration. Non-compliance can lead to penalties, import bans, or product recalls.

US FDA Registration provides several benefits including access to the US market, product credibility, customer trust, regulatory compliance, and enhanced business opportunities globally.

To renew your US FDA Registration, you need to submit a renewal application during the annual renewal period (October 1 to December 31). Make sure that all information is current and accurate.

US FDA Registration is typically valid for a period of 1 year from the date of issue. It must be renewed annually to continue enjoying the benefits of registration.

A US Agent serves as the point of contact for FDA communications and must be located in the United States. They receive all FDA correspondence and help facilitate communication between the FDA and the foreign establishment.

You can get assistance with US FDA Registration by contacting our expert team. We will guide you through the entire process, including document preparation, application filing, US Agent appointment, and follow-ups with FDA.
FDA
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Disclaimer: This page is provided for general informational purposes only and does not constitute legal, tax, or professional advice. Government fees, processing timelines, and documentation requirements are prescribed by the US Food and Drug Administration (FDA) and are subject to change without notice. First Auditor is an independent professional services firm and is not affiliated with, or an agent of, any government department. Please consult our team or a qualified professional for advice specific to your situation before making any registration decision.
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