Facility Registration & Listing
One of the most basic requirements for selling FDA-regulated products is to make sure they are properly registered and sometimes listed with the FDA. The FDA requires food facilities renew their registration every even-numbered year, and any medical device or drug facility must be registered and listed annually. It is a common misconception that both being registered and listed is just filling out a few forms. FDA uses online systems for these submissions. These systems involve huge amounts of technical validation, and often require specific information or formats in order to accept submissions.
Who needs to register?
The requirements for which types of facility in the supply chain must register vary by commodity. Which specific facility must register may depend on your business structure or where your business is in the supply chain. However, as a rule of thumb, the manufacturer and distributor for any FDA-regulated commodity must be registered with the FDA, and in some cases must submit a listing of each of its products.
What is a U.S. Agent?
Foreign manufacturers must identify a verified United States Agent for their establishment to vouch for their product entry into the country. The U.S. Agent must either reside in or maintain a place of business in the U.S. This person must be listed during the registration process.
U.S. agent responsibilities include:
- assisting FDA in communications with the foreign facility;
- responding to questions concerning the foreign facility’s products that are imported or offered for import into the United States;
- assisting FDA in scheduling inspections of the foreign facility; and
- receiving information or documents from FDA, if FDA is unable to contact the foreign establishment directly.
A common question is to wonder if an importer can also act as a U.S. Agent. Acting as the U.S. Agent is a responsibility and a risk; the U.S. Agent’s purpose is to facilitate communications with the foreign facility, but the U.S. Agent can be held responsible for some fees. FDA asks the designated U.S. Agent to confirm their willingness to serve before FDA will finalize the registration. Make sure your importer is willing before you designate them!
Is an FSVP Agent the Same thing as a U.S. Agent?
No, they are not the same. Foreign facilities use U.S. Agents as the point of contact with FDA. Food facilities need an FSVP Agent if there is no U.S. owner or consignee at the time goods enter the U.S. FDA will hold the FSVP Agent responsible for meeting all FSVP requirements. The FSVP Agent must be designated in writing with signed consent by the FSVP Agent.
What Happens if I don’t Register on Time?
Each year thousands of products are subject to import detention because their registration/listings were not at all or not done properly. You may not get caught right away, but Custom’s Automated Commerical Environment (ACE) system for brokers makes it much more likely. Additionally, FDA may delist (inactivate) products from their database when firms have not renewed annual or bi-annual registrations.
How do I get Certified as FDA Approved?
FDA does not issue certificates of FDA approval. Firms that specialize in FDA compliance, like FDAImports, often issue their own certificates verifying that a company has registered their facility with FDA. These certificates can be valuable in facilitating business with suppliers or customers.
What are the different requirements?
All facilities will need to submit a unique facility identifier (UFI) that FDA recognizes as acceptable, such as a DUNS number. Companies may obtain a DUNS number for free from Dun & Bradstreet.
Additionally, each industry has specific rules and pieces of information that FDA requests of them to complete the process.
- When: Prior to manufacturing/processing, packing, or holding food for consumption in the United States.
- Biennial Renewal: food facilities must renew their FDA facility registration between October 1 and December 31 of each even-numbered year.
- Where: Food facility registrations are processed electronically though the FDA Unified Registration Listing Systems (FURLS).
- What: Each registrant must submit information relating to the facility location, owner/operator, operations, emergency contact, alternative trade names, etc.
Overview: FDA regulation requires food facility registration of all food manufacturers no matter where they are located if their food is distributed in the U.S. for human or animal consumption. This requirement applies to conventional foods, pet foods, beverages, dietary supplements and food additives and ingredients. The food facility registration is required under the Bioterrorism Act (BTA). FDA will issue import refusals for an imported food or imported beverage manufactured by a foreign facility that is not registered under the BTA. The Food Facility Registration Number of every foreign manufacturer of imported food or imported beverages must be declared to FDA and U.S. Customs prior to the arrival of the imported food or beverage. This submission happens through the FDA Prior Notice filing. Foreign food firms must also identify a U.S. Agent for FDA purposes.
While facility registration is an important part of manufacturing and distributing food products, there are other regulatory requirements for companies to follow as well. Visit our food and beverage page for more information.
- When: Domestic manufacturers: No more than 5 calendar days after beginning to manufacture, repack, relabel, or salvage the drug intended for human use in the United States. Foreign Manufacturers: must complete registration and drug listing before beginning marketing in the USA.
- Annual renewal: Required for all registered drug establishments annually between October 1 and December 31.
- Where: Drug establishment registration, NDC (National Drug Code) Labeler Codes, and drug listings are created using a Structured Product Labeling (SPL) editor. The files are saved in .xml format and uploaded through FDA’s Electronic Submission Gateway (ESG).
- What: Company must first obtain an NDC Labeler Code (first 5 digits of an NDC Product-Package Code). Assigned by FDA.
- Drug Listing must include:
- Registrant information
- Labeler information
- Establishment information
- Product details (name, active ingredients, inactive ingredients, package sizes, route of administration, warnings, PDP, label, OTC Monograph reference or NDA/ANDA etc.)
Overview: All drug manufacturers, processors, packers, re-packers, labelers, and re-labelers who offer drugs for sale or distribution in the United States are required to register their drug establishments with FDA. The registration regulations apply to domestic drug companies and foreign drug facilities alike. Foreign drug firms must also identify a U.S. Agent for FDA purposes. Every drug establishment registered with FDA must submit, in English, a list of every drug they have in commercial distribution. FDA’s electronic drug registration and drug listing system provides information to FDA on all drug companies manufacturing, processing, packing and labeling drugs for U.S. distribution.
FDA also requires that all registered facilities review and update product listings in June and December of each.
New in 2020, FDA is planning to charge firms a user fee for OTC drugs starting with FY 2021 registration renewals.
While facility registration is an important part of manufacturing and distributing drug products, there are other regulatory requirements for companies to follow as well. Visit our Drugs page for more information.
- When: Prior to marketing and distributing products in the United States. Additionally, all companies are required to pay the user fee prior to completing their registration. They must pay and obtain a Payment Identification Number (PIN) and Payment Confirmation Number (PCN).
- Annual renewal: Required for all registered medical device establishments between October 1 and December 31 of each year.
- Where: Medical device establishment registrations are processed electronically though the FDA Unified Registration Listing Systems (FURLS) via the Device Registration and Listing Module (DRLM).
- What: Each registrant must submit information relating to the establishment location, owner/operator, operations (per device), emergency contact, product details (PMA, 510(k), Product Code), etc.
Overview: Medical device establishments that develop device specifications, manufacture, process, pack, assemble, label, and export or import medical devices must register with FDA. The registering establishment must also list all medical devices (device listing) introduced into the U.S. market before distribution (or importation) begins. In addition, foreign device establishments must register their establishments, identify a U.S. Agent for FDA purposes, and list their devices before importing them into the United States.
FDA charges an annual Device Facility User Fee each year upon renewal.
While facility registration is an important part of manufacturing and distributing medical device products, there are other regulatory requirements for companies to follow as well. Visit our Medical Devices page for more information.
FDA maintains the Voluntary Cosmetic Registration Program (VCRP) for cosmetic establishments and formulations. The VCRP system is designed to help FDA keep track of cosmetic product manufacturers, and the ingredients used in cosmetic products. Although facility registration is mandatory for drug, medical device, and food domestic and foreign firms, Cosmetic Facility Registration is completely voluntary. Current federal law and FDA cosmetic regulations do not require cosmetic manufacturers or cosmetic importers to register with FDA or to list or submit their cosmetics for FDA review prior to marketing in the U.S. As long as your cosmetic is not also a drug (i.e., cosmetics that bear SPF labeling claims), the manufacturer is not required to register.
For more information on other regulatory requirements for cosmetics please visit our Cosmetics page.
How much does it Cost to Use FDAImports for Registration and/or Listing?
Many companies that have been registered with FDA in the past find they cannot navigate the new FDA registration and listing processes. We perform these services regularly for foreign and domestic manufacturers, distributors, importers and foreign exporters. In addition, we perform registration services for food establishments. We also can act as the U.S. Agent for many foreign food, drug and medical device manufacturers for their foreign facility registrations. Please note this is not the same as an FSVP agent, who has substantially different duties.
We assist companies with every aspect of facility registration and product listing. We currently offer low-cost food facility registration in our FDAImports.com Apps Center. For more information about our other registration and listing services please contact us below.