FDA Registration requirements made easy.

The U.S. Food and Drug Administration (FDA) is responsible for protecting public health by regulating imported products. Any company that plans to distribute food, animal, medical, or beauty products for the U.S. market is required to register with FDA.

If you produce products in the categories below, FDA registration may be mandatory:

  • Food, beverages, or dietary supplements
  • Cosmetic products
  • Animal and veterinary products
  • Medical devices
  • Drug products (including OTC)
  • Tobacco products
  • Radiation-emitting devices (RED)
  • Biologics

Each product category has specific exemptions and Registrar Corp can help you determine whether you must register your facility.

By registering your facility with FDA, you help promote consumer safety and keep your company FDA compliant. FDA registration involves submitting detailed information about your products, manufacturing facilities and processes, quality control, labeling, recall procedures, and more.

FDA compliance can seem time consuming and complex, but it doesn’t have to be. More than 30,000 food and beverage, dietary supplement, drug, medical device, and cosmetics companies trust Registrar Corp to help them comply with FDA registration regulations with ease.

Registering Your Food Facility

Does your facility manufacture, process, pack, or hold food or beverages for consumption in the U.S.? Since the Bioterrorism Act of 2002 and the Food Safety Modernization Act (FSMA) of 2011, FDA has required that all food and beverage companies register and renew their registration to help prevent food supply-related attacks, hazards, threats, and emergencies.

Food and beverage facilities must register with FDA before shipping to the U.S. and renew their registration every even-numbered year between October 1 and December 31.

DUNS and UFIs

In 2016, FDA announced that all drug and food facilities must submit Unique Facility Identifiers (UFIs) as part of their FDA registration and renewal. Today, the only UFIs recognized by the FDA are Data Universal Numbering System (DUNS) numbers, unique identifiers developed by credit bureau Dun & Bradstreet (D&B) for business profiling purposes.

All food facilities must include their DUNS number in their registration with FDA. Failure to provide an accurate DUNS number may result in cancellation of the registration.

Registrar Corp’s Food Facility Registration Services

With our FDA Registration services for food and beverage facilities, you get:

  • FDA registration and renewal assistance
  • DUNS number assistance
  • 24/7 U.S. Agent representation
  • Detention assistance
  • Prior Notice filing
  • Mock FDA inspections (for an additional reduced fee)

Cosmetics Registration

In December 2022, Congress passed a bill that grants FDA full regulatory authority over the cosmetics industry. The new bill, which includes provisions from the Modernization of Cosmetics Regulation Act (MoCRA), will require cosmetic companies to register with FDA to market their products in the U.S.

Registrar Corp’s Cosmetics Registration Services

MoCRA establishes significant new requirements for cosmetics manufacturers and processors distributing products in the U.S.

New requirements include:

  • Facility registration
  • Product listings
  • Good Manufacturing Practices (GMPs)
  • Safety substantiation
  • New labeling requirements
  • Adverse event reporting
  • Record keeping

Registrar Corp provides several solutions for MoCRA’s new requirements, including serving as a domestic U.S. Agent, assisting with facility registration and renewal, cosmetic product listing and renewal, guidance with FDA requirements, and much more.

Dietary Supplement Facility Registration

Dietary supplements fall under FDA jurisdiction as part of the food and beverage industry. This means if you’re a dietary supplement manufacturer, processor, packager, or warehouse facility trying to enter the U.S. market, you need to register your facility with FDA.

Like food and beverage facilities, dietary supplement manufacturers, processors, packagers, and warehouse facilities must register with FDA before shipping products to the U.S. and renew their FDA Registration every even-numbered year between October 1 and December 31.

Master Manufacturing Records

Companies that manufacture dietary supplements must write and implement Master Manufacturing Records (MMRs) for each unique formulation and batch size of dietary supplement. MMRs identify steps and stages in the manufacturing process for each supplement to ensure consistency in the components, quality, labeling, and packaging of the supplement across batches.

Registrar Corp’s Dietary Supplement Registration Services

Our FDA Facility Registration services for dietary supplement companies consist of:

  • FDA Registration and Renewal assistance
  • DUNS number assistance
  • 24/7 U.S. Agent representation
  • Prior Notice filing
  • Mock FDA Inspections
  • MMR compliance review

Drug Facility Registration

Registering your drug establishment with FDA helps you bring safe and compliant products to market. FDA registration is mandatory for all domestic and foreign companies that manufacture, prepare, propagate, or compound drug products for commercial distribution in the U.S.

Drug establishments must register with FDA before shipping to the U.S. and must renew their registration annually between October 1 and December 31. In addition, establishments must submit a list of every drug in commercial distribution in the U.S. when they renew.

Drug Master File Submissions

A Master File is a secure, confidential submission of proprietary product data to a regulatory agency, such as the U.S. Food and Drug Administration (FDA), Health Canada, or the National Medical Products Association (NMPA) in China.

Drug Master Files (DMFs) include information on:

  • Drug substances and products
  • Packaging materials
  • Excipients and preparation materials
  • Facilities and their procedures
  • and More

Registrar Corp offers DMF preparation in electronic common technical document (eCTD) format and submission to 18 regulatory bodies worldwide.

Registrar Corp’s Drug Facility Registration Service

With our FDA Registration services for drug facilities, you receive:

  • FDA Registration and Renewal assistance
  • DUNS number assistance
  • 24/7 U.S. Agent representation

Medical Device Registration

Knowing what medical devices are available can impact the U.S.’s ability to respond to public health emergencies. All establishments involved in producing and distributing medical devices intended for use in the U.S. need to register with FDA.

Medical device companies are required to register with FDA before shipping products to the U.S. and must renew their registrations annually between October 1 and December 31.

Medical Device Master File Submissions

Similar to Drug Master Files, Medical Device Master Files (MAFs) contain proprietary product data that is securely submitted to national and international regulatory agencies.

MAFs include information on:

  • Facilities and their procedures
  • Device formulations
  • Packaging materials
  • Clinical and non-clinical study data
  • and More

Registrar Corp offers MAF preparation in electronic common technical document (eCTD) format and submission to 18 regulatory bodies worldwide.

Registrar Corp’s Medical Device Registration Services

With our FDA Registration services for medical device facilities, you get:

  • FDA Registration and Renewal assistance
  • UDI and GUDID assistance and compliance
  • 24/7 U.S. Agent representation
  • Electronic Medical Device Reporting (eMDR)

Other FDA Registrations

Along with food and beverage, cosmetic, drug, medical device, and dietary supplement establishments, Registrar Corp can help companies in the following industries register with FDA:

  • Radiation-emitting devices
  • Tobacco
  • Biologics

Certificate of Registration

Once a company is registered, FDA issues registration numbers but does not provide Certificates of Registration. Yet many buyers or importers still request registration confirmation from their suppliers.

If your facility has already registered with FDA, Registrar Corp can provide a third-party Certificate of Registration to serve as confirmation of your valid FDA registration to buyers, customs brokers, and suppliers. We currently offer third-party Certificates of Registration for companies in the food and beverage, drug, and cosmetics industries.

If your facility is not registered with FDA, consider working with Registrar Corp to register your facility and obtain a third-party Certificate of Registration.

Verify Your FDA Registration

FDA registration numbers can become invalid unexpectedly and cause delays or detentions at ports of entry. Reasons your FDA registration number may be invalidated include:

  • Outdated ownership or other information
  • Registration not submitted by authorized person
  • Facility’s U.S. Agent refusing the designation
  • Registration not renewed before renewal deadline

At Registrar Corp, we provide U.S. FDA registration verification at no additional cost. You can quickly and easily check whether your facility’s registration is valid and take corrective action to prevent potential fees or fines.

Affirmation of Compliance

When a product arrives at a U.S. port of entry, certain information must be provided and transmitted electronically to the United States Customs and Border Protection (CBP). If the product is or may be regulated by FDA, CBP sends the import entry information to the FDA for verification.

Appropriate Affirmation of Compliance (AofC) codes and qualifiers can expedite the admissibility process. While the use of these AofC codes is voluntary, it will help expedite the entry review process and increase the likelihood that the shipment may be processed based on import system screening.

Frequently Asked Questions

Any domestic or foreign facility that intends to produce and distribute the following products for the U.S. market must register with FDA:

  • Food, beverages, or dietary supplements
  • Cosmetics
  • Animal and veterinary products
  • Medical devices
  • Drugs products (including OTC)
  • Tobacco products
  • Radiation-emitting devices (RED)
  • Biologics

All eligible domestic and foreign facilities must register and re-register or update their registration regularly.

Food, beverage, and dietary supplement facilities must register with FDA before shipping to the U.S. and renew their registration every even-numbered year between October 1 and December 31.

Medical device companies and drug facilities are required to renew their registration annually. Drug facilities must also submit a list of every drug in commercial distribution in the U.S. when renewing their registration between October 1 and December 31.

Cosmetic manufacturers and processors must register their facilities with FDA before shipping to the U.S. and renew their registration every two years between October 1 and December 31.

If you forget to register your facility by December 31, you will need to re-register your facility with FDA. If you are not registered and are shipping products to the U.S., your shipments may be detained at port and held, returned, or destroyed.

A UFI is any Unique Facility Identifier recognized by FDA for registration and renewal purposes. FDA currently only recognizes DUNS numbers, unique identifiers developed by credit bureau Dun & Bradstreet, as acceptable UFIs.

A UDI is any Unique Device Identifier created to identify medical devices sold in the U.S. which must be displayed on device packaging, labels, and the device itself.

Food importers are not required to register with FDA unless they manufacture, process, pack, or store foods in addition to importing. But it is essential that they confirm that their suppliers are registered. FDA requires that Prior Notice be submitted for all food imports which cannot be filed without the manufacturer’s registration number.

While food facility registration is not required for importers who do not take physical possession of food, under FDA’s FSMA, importers must monitor and document the compliance status of their suppliers.

According to FDA, domestic or foreign owners or operators must register their place of business (also called a “facility” or “establishment”). FDA classifies each industry differently for registration purposes:

Food and Beverage: Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S.

FDA also classifies companies producing dietary supplements with the food and beverage industry.

Drugs: Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States

Medical Devices: Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.)

Cosmetics: Manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the United States

Radiation-Emitting Products: Manufacturers of any electrically-powered product that can emit any form of radiation on the electromagnetic spectrum

Tobacco: Every person who owns or operates any domestic establishments engaged in the manufacture, preparation, compounding, or processing of a regulated tobacco product

Biologics: Establishment that manufactures human cells, tissue, and cellular and tissue-based products (HCT/Ps)

Sources:
https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions
https://www.registrarcorp.com/how-to-obtain-a-ufi-for-your-food-facility/
https://www.registrarcorp.com/how-to-share-your-food-facilitys-registration-status/
https://www.registrarcorp.com/fsma-compliance-for-food-storage-facilities/
https://www.registrarcorp.com/frequently-asked-friday-do-food-importers-have-to-register-with-fda/
https://www.registrarcorp.com/an-overview-of-fdas-updated-udi-requirements-for-class-1-medical-devices/
https://www.registrarcorp.com/fda-announces-new-medical-device-user-fees-for-fy-2023/
https://www.fda.gov/food/food-safety-modernization-act-fsma/full-text-food-safety-modernization-act-fsma#SEC102
https://www.registrarcorp.com/fda-supplements/

According to U.S. FDA, domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register their facility with FDA. While some companies may refer to this as a license for food businesses, the only term used and accepted by FDA is a food facility registration.

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