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                FDA Basics for Industry

FDA Basics for Industry

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          FDA Basics for Industry
          Registration and ListingFDA Basics for Industry Registration and Listing
  
  	
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    PrintHow to register facilities and products, and how to update registrations

Animal and Veterinary

Domestic and foreign establishments that manufacture, repack, or re-label animal drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This process is done in conjunction with the human drug registration process.

Guidance for Industry - Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing
	Policy & Procedures Manual 1240.3560 – Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
	Step-by-Step Instructions for Creating SPL Files For Electronic Drug Establishment
	Structured Product LabelingCosmetics

FDA stopped accepting and processing both electronic and paper submissions to the voluntary registration program for cosmetics establishments and products on March 27, 2023. We are developing a program for submission of the facility registrations and product listings mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and will provide further updates on its forthcoming availability.  For more information, please visit: Modernization of Cosmetics Regulation Act of 2022.

Drugs

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This information helps the FDA maintain a catalog of all drugs in commercial distribution in the United States.

Drug Registration and Listing System
	Drug Establishments Current Registration SiteFood

Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA.

Registration of Food FacilitiesMedical 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.) are required to register annually with the FDA. This process is known as establishment registration.

Device Registration and ListingRadiation-Emitting Products

Filing Radiation Safety (Product) Reports for radiation emitting products is required by law. The FDA eSubmitter software replicates several reporting guides and forms. The electronic templates currently available in eSubmitter represent most forms industry is required to submit to FDA.

eSubmitter: Radiological Health ProgramTobacco Products

Under section 905 of the Tobacco Control Act, every person who owns or operates any domestic establishments engaged in the manufacture, preparation, compounding, or processing of a regulated tobacco product must register those establishments with FDA by December 31 of each year. All registrants must also submit a list of all tobacco products which are being manufactured by that person for commercial distribution, along with certain accompanying information including all labeling.

Guidance for Industry: Registration and Product Listing for Owners and Operators of Domestic Tobacco Product EstablishmentsFDA strongly encourages electronic submission. For electronic submission of such information, FDA utilizes the Tobacco Registration and Product Listing Module - Next Generation (TRLM NG).

Access Tobacco Registration and Product Listing Module – Next Generation (TRLM NG)Alternatively, you may use Form FDA 3741 for Establishment Registration and Product Listing. Persons with disabilities having problems accessing the above pdf file may call 1-877-CTP-1373for assistance.

Vaccines, Blood, Biologics

If you are an establishment that manufactures human cells, tissue, and cellular and tissue-based products (HCT/Ps), FDA regulations require you to register with the agency and list your HCT/Ps. “Manufacture” includes any or all steps involved in the recovery, processing, storage, labeling, packaging or distribution of HCT/Ps, and the screening or testing of the cell or tissue donor. See below for information on how to register with FDA:

Tissue Establishment Registration
	Human Cell and Tissue Establishment Registration (HCTERS) Public Query ApplicationFDA regulations require all blood establishments that collect, manufacture, prepare, store under controlled conditions for further distribution or process blood and blood products to register. See below for detailed information on blood establishment registration:

Instructions for Completing the Electronic Blood Establishment Registration (BER) and Product Listing Form
	Blood Establishment Registration and Product ListingDomestic and foreign establishments that manufacture, repack, or re-label drug and biologic products, including vaccines, are required to register with the FDA. Domestic and foreign drug and biologics manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug and biologic products. This information helps the FDA maintain a catalog of all drugs and biologics in commercial distribution in the United States.

Drug Registration and Listing System
	Drug Firm Annual Registration Status

                                                                                  Content current as of:
      07/07/2023FDA Basics for Industry

          
                        Guidances
          Registration and Listing
          Regulatory Process
          Product Application and Petition Review Process
          Stay Informed With FDA Program Areas
          Search Databases
          Popular Content
          Industry Frequently Asked Questions
          Educational Resources
          Compliance and Enforcement
          For Trade and Industry Groups: Requesting Cross-Agency Speakers From FDA
          Imports
          Submit Questions and Comments
 
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