Every company that manufactures, processes, packs, or holds FDA-regulated products must register with the FDA before commercial distribution. We handle the entire registration process — so you can focus on your products.
Jared Clark, JD, MBA, PMP, CMQ-OE, RAC, CPGP, CFSQA
FDA registration is a core service of Certify Consulting, our full-service certification and compliance practice.
FDA registration is the mandatory process by which establishments (facilities) that manufacture, process, pack, or hold FDA-regulated products identify themselves to the U.S. Food and Drug Administration. Registration is required under Section 510 of the Federal Food, Drug, and Cosmetic Act and is enforced through corresponding regulations in Title 21 of the Code of Federal Regulations (21 CFR).
Registration is not optional. It is a legal prerequisite for commercially distributing any FDA-regulated product in the United States. Without proper registration, your products are considered adulterated or misbranded under federal law — exposing your company to import alerts, product seizures, injunctions, and civil or criminal penalties.
FDA registration is often confused with FDA approval, but they are entirely different requirements. Registration tells the FDA who you are and where your facility is located. Approval (or clearance, depending on the product) tells the FDA that a specific product is safe and effective for its intended use. Most companies need both — but registration always comes first.
Key distinction: FDA registration covers your facility (establishment). FDA product listing covers your products. Both are required, and they are submitted together through the FDA's electronic systems. Our consulting service handles both simultaneously.
The FDA requires registration from a broad range of entities involved in the supply chain of regulated products. If your business falls into any of the following categories, you are legally required to register your facility before distributing products commercially in the United States.
Any U.S.-based facility that manufactures, prepares, propagates, compounds, assembles, or processes an FDA-regulated product for commercial distribution must register. This includes contract manufacturers who produce products on behalf of other companies, even if they do not market the products under their own brand.
Foreign establishments that manufacture, prepare, propagate, compound, or process products for export to the United States must register with the FDA. This requirement applies regardless of whether the product is shipped directly to the U.S. or passes through an intermediary country. Foreign facilities must also designate a U.S. Agent — a person or company located in the United States who serves as a communication liaison with the FDA.
If your facility repackages or relabels FDA-regulated products, you must register as a separate establishment — even if the original manufacturer is already registered. This is a common oversight that catches companies off guard during FDA inspections.
Companies that perform contract sterilization for medical devices or that develop specifications for finished devices (without manufacturing them directly) are also required to register with the FDA as separate establishments.
Under the FDA Food Safety Modernization Act (FSMA), domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States must register with the FDA. The only exemptions are farms, restaurants, retail food establishments, and certain other entities as defined in 21 CFR 1.226. Food facility registration is managed through the FDA's Food Facility Registration Module (FFRM).
Common mistake: Many companies assume that if they use a contract manufacturer, they do not need to register. This is incorrect. Depending on your role in the supply chain (specification developer, relabeler, initial distributor), you may still need your own establishment registration. We assess your specific situation during our initial consultation.
Our structured approach ensures your facility is registered correctly the first time — no rejected submissions, no missed requirements, no delays.
We evaluate your products, facilities, and business model to determine which FDA registration categories apply and identify any additional regulatory requirements.
We verify or obtain your facility's DUNS number — a prerequisite for FDA electronic registration. We handle the entire Dun & Bradstreet process if you don't have one.
We create or configure your FDA Unified Registration and Listing System (FURLS) account, Device Registration and Listing Module (DRLM), or FFRM account as applicable.
We complete and submit your establishment registration electronically through the appropriate FDA system, including all required owner/operator information and facility details.
We list all commercially distributed products under your registered facility, including proper product codes, proprietary names, and regulatory classifications.
We verify your registration number, confirm product listings are active, set up renewal reminders, and provide ongoing support to keep your registration current.
FDA product listing is the companion requirement to facility registration. Once your establishment is registered, you must list every product that your facility manufactures, prepares, propagates, compounds, or processes for commercial distribution in the United States.
Product listing requirements vary by product category, but the core obligation is the same: the FDA needs to know what you make, where you make it, and how it is classified under federal regulations.
Drug establishments must list every drug product they manufacture for commercial distribution using the Drug Registration and Listing System (DRLS). Each listing requires the drug's proprietary name, established name, active ingredients, dosage form, route of administration, NDC numbers, and labeling. Both prescription and over-the-counter (OTC) drugs must be listed.
Device establishments must list all devices they manufacture using the Device Registration and Listing Module (DRLM). Listings require FDA product codes, proprietary names, regulatory class (I, II, or III), premarket submission numbers (510(k), PMA, or De Novo where applicable), and activities performed at the facility (manufacture, repack, relabel, sterilize, etc.).
While food facilities register through the Food Facility Registration Module (FFRM), they must also identify the general food product categories they handle. Unlike drugs and devices, food facilities do not list individual products — but they must declare applicable food product categories and indicate whether they handle any products subject to the Bioterrorism Act's prior notice requirements.
Listing updates: Product listings must be updated whenever you add new products, discontinue existing products, or change product information. Drug listings must be updated in June and December of each year. Device listings must be kept current at all times. Failure to maintain accurate listings is a citable deficiency during FDA inspections.
Every foreign establishment that registers with the FDA must designate a U.S. Agent — a person or company located in the United States who acts as a communication liaison between the foreign facility and the FDA. The U.S. Agent requirement applies across all product categories: drugs, medical devices, food, and dietary supplements.
The U.S. Agent must reside in the United States or maintain a place of business in the United States. The U.S. Agent cannot be a mailbox, answering service, or P.O. Box. The agent must be an actual person or entity capable of receiving and responding to FDA communications in real time.
Many foreign manufacturers designate their U.S. importer, distributor, or customs broker as their U.S. Agent. However, this creates a potential conflict of interest — your commercial partner may not have the regulatory expertise to handle FDA communications effectively. We provide professional U.S. Agent services with regulatory expertise built in, ensuring that FDA communications are handled promptly and competently.
Our U.S. Agent service includes: 24/7 availability for FDA communications, regulatory expertise to handle FDA inquiries, inspection coordination support, immediate notification of any FDA correspondence, and ongoing compliance monitoring for your registered facility.
FDA registration is not a one-time event. Understanding the registration windows and renewal deadlines is critical to maintaining your facility's legal status and avoiding enforcement actions.
New establishments must register with the FDA before beginning commercial distribution of any FDA-regulated product. There is no grace period. If you begin manufacturing or distributing products without a valid registration, your products are considered adulterated under federal law.
Drug and device establishment registrations must be renewed annually between October 1 and December 31 of each year. The renewal window is non-negotiable — if you miss it, your registration lapses and your facility is no longer considered registered with the FDA.
Food facility registrations operate on a biennial cycle. Renewals are required during even-numbered years (2024, 2026, 2028, etc.) between October 1 and December 31.
Consequences of lapsed registration: A lapsed registration can trigger import alerts (blocking your products at the border), FDA warning letters, product detention, refusal of admission for imported goods, and potential debarment. We proactively manage renewal deadlines for all clients to prevent these outcomes.
A Data Universal Numbering System (DUNS) number is a unique nine-digit identifier assigned by Dun & Bradstreet (D&B) to identify business entities. The FDA requires a valid DUNS number as a prerequisite for electronic establishment registration across all product categories.
The DUNS number serves as the facility's unique identifier within the FDA's registration systems. It links your physical facility to your FDA registration, product listings, and any compliance history. Without a valid DUNS number, you cannot complete the electronic registration process.
If your facility does not already have a DUNS number, you must request one from Dun & Bradstreet before initiating the FDA registration process. The standard request process is free of charge but can take up to 30 business days. Expedited processing is available for a fee, typically within 1–5 business days.
For facilities with multiple physical locations, each location that will be registered with the FDA needs its own DUNS number. Headquarters and branch facilities each require separate DUNS assignments.
We handle the DUNS process: As part of our registration consulting service, we verify whether your facility already has a DUNS number, request one if needed, and ensure the D&B records match your FDA registration information. Mismatched DUNS data is one of the most common causes of registration rejections.
FDA registration fees vary by product type and are set annually by the FDA under PDUFA, MDUFA, and GDUFA legislation. Below are the approximate current fee structures.
Note on fees: FDA registration fees are adjusted annually and published in the Federal Register. The figures above are estimates for FY2026. We confirm current fee amounts during your initial consultation and factor them into your project budget. Our consulting fees for the registration process itself are separate from FDA's statutory fees.
After helping hundreds of companies through the FDA registration process, we've identified the most frequent errors that delay registrations, trigger FDA enforcement, or create compliance gaps.
Facilities must register before distributing products — not after. Operating without registration exposes you to seizure, injunction, and import refusal.
Registering as the wrong establishment type (e.g., manufacturer vs. relabeler) creates compliance gaps that surface during inspections.
When your Dun & Bradstreet records don't match your FDA registration details, the system rejects your submission or creates duplicate records.
Registration alone is not enough. You must also list every product you manufacture. Missing product listings are a common 483 observation.
Foreign facilities that register without a valid U.S. Agent are non-compliant. The FDA can refuse registration entirely if no U.S. Agent is designated.
Failing to renew between October 1 and December 31 causes your registration to lapse, potentially triggering import alerts and product holds.
While the core requirement to register is universal, the specific regulations, systems, and processes differ significantly between product categories. Each FDA center maintains its own registration infrastructure, and the compliance obligations that accompany registration vary by industry.
Drug establishment registration is governed by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for biological products. Drug establishments register and list products through the Drug Registration and Listing System (DRLS), accessed via the FDA's Unified Registration and Listing System (FURLS).
Key considerations for drug establishment registration include:
Medical device registration falls under the Center for Devices and Radiological Health (CDRH). Device establishments register through the Device Registration and Listing Module (DRLM) within FURLS.
Key considerations for device establishment registration include:
Food facility registration is governed by the Center for Food Safety and Applied Nutrition (CFSAN) under the authority of FSMA. Food facilities register through the Food Facility Registration Module (FFRM).
Key considerations for food facility registration include:
Multi-product facilities: If your facility manufactures products across multiple FDA-regulated categories (for example, both drugs and medical devices), you may need separate registrations under each applicable regulation. We assess your complete product portfolio during our initial consultation to ensure every registration requirement is identified and addressed.
FDA registration is just the first step. Most companies also need support with inspections, compliance systems, and regulatory submissions.
Once registered, your facility is subject to FDA inspections. We prepare your team with mock inspections, documentation review, and real-time inspection support.
Learn moreOngoing compliance support including annual registration renewals, product listing updates, CGMP maintenance, and post-market surveillance.
Learn moreFor medical device companies, facility registration is just the beginning. We guide your 510(k) submission from predicate selection through FDA clearance.
Learn moreCommon questions about FDA facility registration, product listing, and the registration process.
Don't risk registration errors, missed deadlines, or compliance gaps. Schedule a free consultation with Jared Clark, RAC — we'll assess your registration requirements and handle the entire process from DUNS number through product listing.