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Step-by-Step Process to Register With the U.S. FDA

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Financial Analyst

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Step 1: Determine FDA Product Category

Identify whether your product falls under:

  • Food facility registration (FURLS/FSMA)
  • Drug Establishment Registration
  • Medical Device Establishment Registration (via FURLS/CDRH)
  • Cosmetic voluntary registration (VCRP)

Different categories use different FDA portals.

✔ Step 2: Appoint a U.S. FDA Agent (Mandatory for Foreign Companies)

Foreign companies must appoint a U.S. Agent, who will:

  • Communicate with FDA on your behalf
  • Receive FDA notifications
  • Assist in inspections or compliance issues

Without a U.S. Agent, FDA registration cannot be completed.

✔ Step 3: Obtain a DUNS Number (For Food Facility Registration)

The DUNS Number is required for:

  • Food manufacturers
  • Seafood processors
  • Dietary supplement facilities

Apply through Dun & Bradstreet.

✔ Step 4: Create FDA Account on FURLS

Visit: https://www.access.fda.gov
Create an account on the FDA Unified Registration and Listing System (FURLS).

Provide:

  • Business details
  • Email verification
  • Facility information

✔ Step 5: Submit Facility Registration Application

Choose the appropriate module:

  • Food Facility Registration (FFR)
  • Drug Establishment Registration (DRLS)
  • Medical Device Registration (CDRH)

Fill in:

  • Facility details
  • Owner/operator information
  • U.S. Agent details
  • Product category
  • Manufacturing processes

✔ Step 6: Pay FDA Registration Fees (For Drugs & Devices Only)

FDA food facility registration is free.
However, drug and medical device establishments must pay annual fees.

✔ Step 7: Receive FDA Registration Number

Once approved, FDA issues:

  • FDA Facility Registration Number
  • FEI Number (for some categories)
  • Device listing or drug listing confirmation (if applicable)

This number may be required by importers and U.S. customs brokers.

✔ Step 8: Comply With FDA Labeling & Packaging Standards

Ensure labels follow:

  • Ingredient declaration
  • Nutritional facts (for food)
  • Warning statements
  • Allergen labeling
  • Drug Facts / Device Instructions

Incorrect labeling can result in shipment refusal.

✔ Step 9: Respond to Inspections or FDA Queries

FDA may request:

  • Additional documents
  • Product sample testing
  • Facility inspection (physical or remote)

Always maintain compliance records.

✔ Step 10: Renew Registration Annually

FDA registrations require renewal:

Food Facility Registration

  • Every 2 years (even-numbered years)

Drug & Medical Device Registration

  • Annually
  • Requires annual fee payment

Failing to renew leads to registration cancellation.

Common Mistakes to Avoid

  • Using incorrect product classification
  • Not appointing a reliable U.S. Agent
  • Missing renewal deadlines
  • Incomplete labeling compliance
  • Failing to maintain test reports & certificates

SavingMantra recommends reviewing FDA guidelines before exporting.

Frequently Asked Questions (FAQ)

1. Does FDA provide a certificate after registration?

No. FDA provides a registration number, not a certificate of approval.

2. Is FDA registration mandatory for food exporters?

Yes — food facility registration is compulsory.

3. How long does FDA registration take?

Typically 3–10 working days if documents are accurate.

4. Can FDA reject an application?

Yes, if documents or processes do not meet regulatory standards.

5. Is labeling approval required?

FDA does not pre-approve labels, but they must comply with regulations.

Conclusion

Registering with the U.S. FDA is essential for exporters who wish to sell food, drugs, medical devices, cosmetics, or supplements in the U.S. market. With proper documentation, a U.S. Agent, and accurate product classification, the process can be smooth and efficient. FDA compliance not only ensures legal entry into the U.S. market but also strengthens global credibility.

At SavingMantra, we help businesses with:
✔ FDA Registration (Food, Drug, Device, Cosmetic)
✔ U.S. Agent Appointment
✔ Labeling Compliance Review
✔ Product Classification Support
✔ Annual FDA Renewal Management

WordPress Disclaimer (Add at Bottom of Blog)

Disclaimer: This blog is for informational purposes only. U.S. FDA regulations, requirements, and processes may change over time. Readers should consult official FDA guidelines or a qualified compliance professional before acting on any information provided. SavingMantra is not responsible for any errors, omissions, or regulatory updates affecting the details provided in this article.

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