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Company Contact Information

Company / Business Legal Name *

Street Address *

City *

State / Province *

ZIP / Postal Code *

Country

Primary Contact Full Name *

Primary Contact Title

Business Phone Number *

Business Email Address *

Website URL

Purpose Of Inquiry

FDA Registration Type(s) Needed *Food Facility RegistrationDrug Establishment RegistrationCosmetic Facility Registration (MoCRA)Medical Device Establishment Registration

New Registration or Renewal? *NewRenewal

Existing FDA Registration Number

Domestic or Foreign Facility? *DomesticForeign

Designate FDA Entry Point as U.S. Agent?Yes — Designate FDA Entry Point (fees apply)No — I have my own U.S. Agent

Additional Notes or Special Requests

FDA Registration Service Confirmation

FDA Registration Service Confirmation *Yes — Proceed with registration serviceNo — I will complete registration on my own

US Agent

US Agent Name (for foreign facilities) *

US Agent Email (if not available, enter "N/A") *

US Agent Phone Number (Including Country/Area Code)

US Agent Phone Extension

Food Services ChargesUS Agent Services – $295/yrFood Facility Registration – $249Prior Notice (Imports) – $30/filingFood Label Review – $249Dietary Supplement Registration – $249Animal and Vet Registration – $249

Drugs & Pharma Services ChargesUS Agent Services – $295/yrDrug Establishment Registration – $449/yrDrug Product Listing (NDC) – $299/productStructured Product Labeling (SPL) – $249/submissionDrug Label Review – $449/productAnimal and Veterinary Drugs – $449

Cosmetics Services ChargesUS Agent Services – $295/yrCosmetic Facility Registration – $449Cosmetic Product Listing – $299/productCosmetic Label Review – $449/productResponsible Person Designation – $295/yr

Medical Device Services ChargesUS Agent Services – $295/yrDevice Establishment Registration – $349/yrMedical Device Listing – $50/deviceStructured Product Labeling (SPL) – $249/submissionDevice Label Review – $449/productTobacco Product Registration – $449/yr

Pay with Credit / Debit Card *

A service fee is required to proceed with FDA Entry Point’s registration service. Your card will be charged upon clicking ‘Next Step’. This fee is non-refundable once the registration submission has been initiated.

Food, Beverages, Dietary Supplements Registration

Upload Documents — Optional

Drag and Drop (or) Choose Files

Upload existing registration documents, certificates, or completed forms. Our team will extract the required information. Fields below may be left blank if your documents contain all necessary information.

Prefer to complete this section later? *Yes — uploaded documents will provide required informationYes — complete after speaking with your teamNo — fill in the information now

Facility / Establishment Information

Facility Legal Name *

Facility Physical Street Address

Facility Physical City

Facility Physical State/Province

Facility Physical ZIP / Postal Code

Facility Physical Country

Mailing Address same as Physical Address?Yes — use physical address as mailing address

Facility Mailing Address *

Facility Phone Number

Facility Fax Number

Facility Email Address

Type of Activity at Facility

Food Product Categories Handled

Season of OperationYear-RoundSeasonal

Seasonal Start Month

Seasonal End Month

FDA Food Facility Reg. Number

Owner / Operator Information

Owner / Operator Full Legal Name

Same as Primary Contact?Yes — same as Primary Contact (Step 1)If checked, auto-populate from Step 1 contact information

Owner / Operator Business Address

Owner / Operator Phone Number

Owner / Operator Email Address

U.S. Agent Full Legal Name

Product Information

FDA Product Category

Product Brand Name(s)

Product Description

Intended ConsumptionHuman ConsumptionAnimal ConsumptionBoth

Drug Establishment Registration

Upload Documents

Drag and Drop (or) Choose Files

Prefer to complete this section later? *Yes — uploaded documents will provide required informationYes — complete after speaking with your teamNo — fill in the information now

Facility / Establishment Information

Establishment Legal Name

Physical Address

Mailing Address same as Physical Address?Yes — use physical address as mailing address

Mailing Address

Phone Number

Fax Number

Email Address

Type of Establishment Activity

DEA Registration NumberRequired only if facility handles controlled substances

Type of Drugs Handled

FDA Drug Establishment Reg. No.Conditional — shown only if Renewal selected in Step 1

Do you have a DUNS Number?YesNo

Enter DUNS Number

Would you like FDA Entry Point's assistance obtaining a DUNS Number? (Additional fees apply)Yes — please assist with DUNS NumberNo

Owner / Operator Information

Same as Primary Contact?Yes — same as Primary Contact (Step 1)If checked, auto-populate from Step 1 contact information

Owner / Operator Full Legal Name

Business Address

Phone

Email Address

Official Correspondent Full Name

Official Correspondent Phone

Official Correspondent Email

Certification Signature *

Certifies all submitted information is accurate and complete

Date of Certification

U.S. Agent Information

Designate FDA Entry Point as U.S. Agent?YesNo

U.S. Agent Full Legal Name

U.S. Agent Business Address

U.S. Agent Phone Number

U.S. Agent Fax Number

U.S. Agent Email Address

Emergency Contact Phone

Agent Consent ConfirmationYes

Drug Product Listing Information

Proprietary (Brand) Name

Established (Generic/INN) Name

NDC — National Drug Code

Dosage Form

Route of Administration

Strength

Active Ingredient(s)

Inactive Ingredient(s)

Drug Listing Status

Labeler Code

OTC or PrescriptionOver-the-Counter (OTC)Prescription Only

Cosmetic Facility Registration (MoCRA)

Upload Documents

Drag and Drop (or) Choose Files

Prefer to complete this section later? *Yes — uploaded documents will provide required informationYes — complete after speaking with your teamNo — fill in the information now

Company / Establishment Information

Facility / Establishment Legal Name

Facility Phone Number

Facility Email Address

Responsible Person

Owner / Operator Information

Owner / Operator Full Legal Name

Same as Primary Contact?Yes — same as Primary Contact (Step 1)If checked, auto-populate from Step 1 contact information

Owner / Operator Phone Number

Owner / Operator Email Address

Responsible Person Same as Owner?Yes — Responsible Person is same as Owner/OperatorIf checked, auto-populate Responsible Person fields in Category 1 from Owner fields

U.S. Agent Information

Designate FDA Entry Point as U.S. Agent?YesNo

U.S. Agent Full Legal Name

U.S. Agent Business Address

U.S. Agent Phone Number

U.S. Agent Fax Number

U.S. Agent Email Address

Emergency Contact Phone

Agent Consent ConfirmationYes

Facility Information

FDA Cosmetic Facility Reg. NumberRequired for renewal — used to locate the existing registration record

Facility Legal Name

FDA Establishment Identifier (FEI)

Add Another Facility?Yes — Renewal’ selected for Add Another FacilityYes — Initial Registration’ selected for Add Another FacilityNo – selected for Add Another Facility

Facility Legal Name

FDA Establishment Identifier (FEI)

Trade / DBA Name(s)

Facility Physical Address

Facility Mailing Address

Facility Phone Number

Facility Fax Number

Facility Email Address

Type of Facility Activity

Number of Employees at Facility

Season of OperationYear-RoundSeasonal

Seasonal Start Month

Seasonal End Month

Cosmetic Product Listing Information

Product Name

Cosmetic Category

Responsible Person for this Product

Professional Use Only?YesNo

FDA Product Listing Number

Do you need Label Review assistance?YesNo

Full Ingredient ListRequired when Label Review is selected. List all ingredients in descending order using INCI naming convention.

Add Another Product?Yes

Repeater Products

Product Name

Cosmetic Category

Responsible Person for this Product

FDA Product Listing Number

Medical Device Establishment Registration

Upload Documents

Drag and Drop (or) Choose Files

Prefer to complete this section later? *Yes — uploaded documents will provide required informationYes — complete after speaking with your teamNo — fill in the information now

Facility / Establishment Information

Legal Establishment Name

Physical Address

Mailing Address same as Physical Address?Yes — use physical address as mailing address

Mailing Address

Phone Number

Fax Number

Email Address

Type of Establishment Activity

FDA Establishment Identifier (FEI)

Annual User Fee Payment Status

Do you have a DUNS Number?YesNo

Enter DUNS Number9-digit number required for FURLS submission

Would you like FDA Entry Point's assistance obtaining a DUNS Number? (Additional fees apply)Yes — please assist with DUNS NumberNo

Owner / Operator Information

Owner / Operator Full Legal Name

Same as Primary Contact?Yes — same as Primary Contact (Step 1)If checked, auto-populate from Step 1 contact information

Business Address

Phone Number

Email Address

Official Correspondent Full Name

Official Correspondent Phone

Official Correspondent Email

U.S. Agent Information

Designate FDA Entry Point as U.S. Agent?YesNo

U.S. Agent Full Legal Name

U.S. Agent Business AddressU.S. street address — P.O. Box alone not accepted

U.S. Agent Phone NumberMust be U.S.-reachable

U.S. Agent Fax NumberOptional

U.S. Agent Email Address *

Emergency Contact Phone

Agent Consent Confirmation *Yes

Medical Device Listing Information

Device Trade / Brand Name

Common / Generic Device Name

FDA Device Classification

FDA Product Code

510(k) Clearance NumberConditional — required if device received 510(k) clearance

PMA Approval NumberConditional — required for Class III devices with PMA approval

510(k) Exempt?Yes — ExemptNo — Not ExemptUnsure (we will advise)

Listing Activity Type

GMDN Code

Required Certifications & Submission Authorization

Certification of Accuracy & Submission Authorization *I certify that the information submitted in this registration is truthful, accurate, and complete to the best of my knowledge. I understand that the submission of false information is a federal offense.I am authorized to submit this registration on behalf of the registering facility or company, and I have the legal authority to do so.I authorize FDA Entry Point to submit this registration to the U.S. Food and Drug Administration on my behalf using the information provided.

Service Terms & Payment Acknowledgment *I have read and agree to FDA Entry Point’s terms of service, including all applicable fees, timelines, and service conditions.I understand that service fees are non-refundable once FDA registration submission has been initiated, and that additional fees may apply for amendments or renewals.

U.S. Agent Fee Acknowledgment *I acknowledge the annual U.S. Agent service fee and authorize its renewal until I provide written notice of termination.

Certifying Individual Full Name

Certifying Individual Title

Relationship to Facility / Company

Certifying Individual Email

Certifying Individual Phone

Date of SignatureAuto-populated with today’s date. Client may not backdate.

Electronic Signature *

REQUIRED. Typed legal name serves as electronic signature. Must match Certifying Individual Full Name in Section A.

Please do not fill in this field.