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How To Register With The FDA

The US FDA requires facilities that are engaged in manufacturing, processing, packaging, or storing food pharmaceuticals and medical devices sold in the United States to register with the FDA. Therefore, pharmaceutical and device manufacturers must list their facilities and list the products. Companies must annually renew the registration and listings.  FDA US agent is required for foreign facility registration who can also assist with registration and listing.

The number of laws and oversight can be very overwhelming if you are new to the US market. It’s much better to adopt from the very start instead of trying to fix mistakes after they’ve happened.

How to register with the FDA

How to register with the FDA


General Steps for FDA Registration –

  1. Identify the product category
  2.  Create the FURLS account /CDER Account
  3. If you are a food facility, obtain a DUNS number. DUNS number is mandatory for food facility registration.
  4.  Appoint a US agent. US agent appointment is mandatory for all types of registrations
  5.  Prepare   and review the registration
  6. Submit the registration to the FDA.

FDA Registration and Listing  of Medical Devices:

You must register your organization with the FDA if you are a manufacturer, exporter, specification developer, or initial importer of medical devices. Distributors are exempted from the

  • To register and list your information, log on to FURLS (FDA Unified Registration and Listing System). A user ID and password for accessing the FURLS must be available to the holder or operator. You must create one if you don’t have a FURLS account.

An experienced   FDA consultant can offer you medical device registration and listing services, saving you time and effort.

FDA Drug  Establishment Registration  and NDC drug listing  

FDA Drug establishment registration is a mandatory requirement for the companies that manufacture, process, pack, or hold the drug. Such facilities are also required to list the products manufactured in their facility.

Private label distributors are required to list the products which they distribute.

It is mandatory to renew drug establishment registration annually and update the drug listings between 1st October and 31st December every year.

Foreign drug establishments are required to appoint US Agent for FDA registration purposes. US Agent acts as a point of contact between the foreign company and the FDA. US Agent plays an important role in your business.

Food/drinks and dietary supplements registration requirements 

Each food company (domestic or external) manufacturing, storing, packaging, or keeping food for consumption by humans in the United States shall register its company with the FDA. Facilities are also required to renew the food facility every even year, such as 2020, 2022 …

FDA examples from “foods” that may be produced in a registration facility but are not limited to how to Register Food & Diet supplements

  • Raw food products of the farm,
  • Drinks, including alcoholic beverages
  • And water bottles of dairy products
  • And eggs dietary supplements
  • Animal feeding-stuffs

A separate registration number is provided for each food facility. You might need to register and receive separate registration numbers for food facilities if you own or run many facilities. The second facility may also be required to register if your service is transferred to another installation.

Under the Food Safety and Modernization Act (FSMA), the international establishment will provide the FDA with a designated U.S. agent’s name and contact information. Such agents are the contact link between the food plant and the FDA.

FDA Cosmetic Industry Registration:

Cosmetic facilities must register with the FDA as per the MoCRA act.

FDA has discounted Voluntary Program (VCRP) is voluntary. Below are the general compliance FDA compliance requirements for cosmetic products.

  • Cosmetics should not make disease-curing or treatment  claim
  • The product should comply with FDA labeling requirements for cosmetics
  • The ingredient does not cause the cosmetic to be adulterated or misbranded
  • The product should be safe to use