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U.S. FDA Compliance Tools

Registrar Corp offers a variety of free and low cost tools to facilitate compliance with U.S. Food and Drug Administration (FDA) requirements.

Prior Notice Express

Prior Notice must be submitted to FDA for all shipments entering the U.S. containing food, beverages, and dietary supplements. Registrar Corp’s Prior Notice Express makes filing quick and easy and decreases potential filing errors. Users can store information to reduce filing times on future shipments.

File Prior Notice

FSMA Compliance Tools

Requirements under FDA’s Food Safety Modernization Act (FSMA) may depend on the size of a business, its functions, the types of food it handles, and even its location. Registrar Corp’s tools help facilities identify and comply with their FSMA requirements.

FSMA Wizard

Registrar Corp’s FSMA Wizard is a free tool to help food facilities, importers, and farms determine their possible requirements under FSMA. Users simply answer a series of questions regarding your facility, and the FSMA Wizard identifies specific requirements that may apply.

Learn Your Requirements For Free

FDA Compliance Monitor®

FSMA requires covered food facilities and US importers to monitor and document the compliance statuses of each of their suppliers. Registrar Corp’s FDA Compliance Monitor® allows users to easily monitor any FDA Import Alerts, Warning Letters, Import Refusals, or Inspection Classifications related to their suppliers.

Monitor Your Suppliers

FCE Compliance Tools

Food facilities that produce certain shelf-stable, hermetically-sealed low-acid canned or acidified foods must obtain an FDA Food Canning Establishment (FCE) registration and file documentation (Process Filings/SIDs) for each process used in the production of Low-Acid Canned and Acidified Foods.

FCE Wizard

Registrar Corp’s FCE Wizard is a free tool that allows users to identify whether their products are subject to FCE and SID regulations. Users simply answer a few questions, and the FCE Wizard generates a free report indicating possible requirements for each of the facility’s products based on factors such as pH, water activity, and ingredients.

Learn Your Requirements for Free

FCE-SID Verifier

Registrar Corp’s SID Verifier is a free tool that allows users to verify whether SIDs are currently on file in FDA’s database. Manufacturers, importers, and customs brokers must submit valid SIDs as “Affirmation of Compliance Codes” (AofC) when importing FCE products into the United States.

Verify Your SIDs are on File

Registrar Corp's FDA Registration Service

When you designate Registrar Corp to renew your FDA registration, you receive year-round benefits at no additional cost, including:

- Registration renewal and updates as required
- U.S. Agent for FDA Communications (Required for Non-US Facilities)
- Qualified Facility Attestation Guidance
- Certificate of Registration issued by Registrar Corp
- Three free Prior Notice filings each year
- Detention Assistance
- DUNS Assistance
- Mock FDA Inspection: Onsite expert assistance at a discounted rate
- FDA Compliance Monitoring for your facility

Registrar Corp's Registration Service

Registrar Corp's Registration service includes:
  • Certificate of Registration Issued by Registrar Corp: Provides confirmation of your facility’s registration to industry
  • Registration Updates for the Current Year: Registrations must be updated within 60 days of a change in required information
  • Prior Notice: Three free Prior Notice filings each year for products you may import
  • Detention Assistance: Communication with FDA on your behalf to seek the release of a detained shipment
  • DUNS Assistance: Obtain a DUNS number or update an existing DUNS record
  • FDA Compliance Monitoring: A unique system that continuously monitors your company’s FDA compliance status.

U.S. FDA Food Facility Registration Certificate

U.S. Food Facility Registration Certificate

FDA Registration and U.S. Agent Fees

‌US Food Facility Registration:$195 (Includes Certificate)
Non-US Food Facility Registration and U.S. Agent: $695 (Includes Certificate)
‌Certificate Only: $195

Prior Notice Fees

$19.95 per shipment

Discounts available for multiple shipments.

Labeling and Ingredient Review Fees

Labeling Review: $1,495 per product
Label Creation: $1,995 per product

Discounts available for multiple products.

Food Canning Establishment (FCE) and Process Filings (SID) Fees

FCE-SID Filing Service (First Year): $1,995
FCE-SID Filing Service (Annual Renewal): $995
FCE-SID Exclusion Certificate: $399 per product

Shell Egg Registration Fee

Shell Egg Registration: $195

FDA Dairy List Fee

Dairy List Petition: $1495

Certificate of Registration Fee

Certificate of FDA Registration: $195

Food Contact Substances (FCS) Fee

Food Contact Substance Review: $1,495 per product

Color Additive and Color Batch Certification Fees

Color Additive Report: $395 per color
Color Batch Certification Filing: $395 per batch

Data Universal Numbering System (DUNS)

Registrar Corp can obtain a Data Universal Numbering System
(DUNS) Number for your facility at no cost.

U.S. FDA Medical Device Establishment Registration Certificate

U.S. Food Facility Registration Certificate

FDA Registration and Listing Fees

FDA Device Establishment Registration: $150
Medical Device FDA Agent (includes Official Correspondent, U.S. Agent, GUDID Regulatory Contact, and eMDR Authorizing Official): $995 (Annual Fee)
Device Listings: $195 per product code

Labeling and Product Review Fees

Labeling or Product Review: $1,495 per product
Label Creation: $1,995 per product

Discounts available for multiple products.

Electronic Medical Device Reporting (eMDR) Fees

Registrar Corp submits adverse event reports for Official Correspondent and U.S. Agent Clients at no cost.

U.S. FDA Drug Establishment Registration Certificate

U.S. Food Facility Registration Certificate

Unique Device Identifier (UDI) Submission Fees

Single Submission: $95
Block of 10: $495 ($49.50 per submission)
Block of 25: $995 ($39.80 per submission)
Block of 50: $1,495 ($29.90 per submission)
Block of 100: $1,990 ($19.90 per submission)
Block of 500: $7,250 ($14.50 per submission)
Block of 1000: $9,950 ($9.95 per submission)

Medical Device Master File (MAF) Fees

MAF Submission: $1,495
MAF Agent for FDA Communications: $995 (Annual Fee)

Drug Master File (DMF) Fees

DMF Submission (CTD to eCTD): $1,995
For non-CTD submissions, Contact Registrar Corp
DMF Agent for FDA Communications: $995 (Annual Fee)

3PL/WDD Reporting Fees

3PL/WDD Reporting: $995 (Annual Fee)

FDA Registration and Listing Fees

FDA Drug Establishment Registration: $845
Registrant Contact and U.S. Agent: $995 (Annual Fee)
Drug Listings: $645 per listing

Self-Identification Fee

Self-Identification Submission: $995

Registrar Corp submits self-identification information to FDA for Registrant Contact and U.S. Agent Clients at no cost.

Outsourcing Facility Fee

Registration and Registrant Contact: $1995

Adverse Event Contact Fee

U.S. Adverse Event Contact for OTC Labels: $500

Export Certificate Fees

Export Certificate: $195
FDA may charge additional fees for copies of a certificate.

Radiation-Emitting Electronic Device Registration

Initial Product Report: $995
Annual Report: $495
Abbreviated Report: $995
Supplemental Report: $395
Agent for FDA Communications: $695

California Safe Cosmetics Act Certificate

Cosmetic Registration and Filing Fees

Cosmetic Registration: $395

Single Filing: $695
Block of 10: $3950 ($395 per filing)
Block of 25: $5,625 ($225 per filing)
Block of 50: $6,250 ($125 per filing)
Block of 100: $7,500 ($75 per filing)

Discounts available when filing with both
FDA and the State of California.

Cosmetic/Drug Registration Fee

Cosmetic/Drug Registration: $845
Registrant Contact and U.S. Agent: $995 (Annual Fee)
Cosmetic/Drug Listings: $645 per listing

Detention Assistance

Registrar Corp's fee for detention assistance is dependent on the cause of detention. Please call for a quote.

Fees for Food Safety Services

Food Safety Plan (First Product): $1995
Food Safety Plan (Additional Products): $995
HACCP Plan Review: $1995
HACCP Plan Creation: $1995
Foreign Supplier Verification Program: $1995
Foreign Supplier Verification Program (Additional Products): $995
Foreign Supplier Verification Program Agent: Price varies by location. Contact Registrar Corp
Voluntary Qualified Importer Program: Contact Registrar Corp
Food Defense Plan: $1995
Mock FDA Inspection: Contact Registrar Corp

Tobacco Registration and Listing Fees

Authorized Agent: $495
Tobacco Facility Registration: $195

Single Listing: $195
Block of 10: $1,750 ($175 per listing)
Block of 25: $3,750 ($150 per listing)
Block of 50: $6,250 ($125 per listing)
Block of 100: $9,500 ($95 per listing)

U.S. Adverse Event Contact for OTC Labels

U.S. Adverse Event Contact for OTC Labels: $500

U.S. Adverse Event Contact for Dietary Supplement Labels

U.S. Adverse Event Contact for Dietary Supplement Labels: $500


Contact Registrar Corp for Pricing

Master Manufacturing Records (MMRs) Fees

First Master Manufacturing Record Review: $2495
Additional Master Manufacturing Record Reviews: $1495 each