FDA Facility Registration & Renewals (FDA Medical Device, Food & Drugs)

FDA Facility Registration & Renewals (FDA Medical Device, Food & Drugs)

Quality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and Drug FDA domestic and foreign facilities!  With the facility renewal period fast approaching we’re going to touch upon the FDA Facility Registration and Renewal process for domestic/foreign medical devices, food, and drug facilities.

Why is Food Facility Registration & Renewal Important?

Individuals such as owners, operators, or agents that oversee domestic or foreign facilities that manufacture, process, or package food for consumption in the United States are required to register their food facility with the FDA. This requirement along with the FDA being given advance notice on shipments of imported food (Prior Notice of Imported Foods) became effective by the Bioterrorism Act on December 12th, 2003, as a protective to protect the U.S. food supply.

FDA Facility Renewal and Registration

Can the FDA suspend my Food Facility?

The FDA Food Safety Modernization Act (FSMA) which was started on January 4th, 2011, amended section 415 of the FD&C Act. As a result, additional registration information may be required, and the FDA can suspend the registration of a food facility if:

  1. The FDA finds the food held at the facility has a reasonable probability of causing serious adverse health consequences or death.
  2. The facility created, caused, or was otherwise responsible for such a reasonable probability
  3. The facility was aware or had reason to know of such reasonable probability, yet still packed received, or held food ignoring the potential for risk

For help obtaining your FSVP certification and/or registering/renewing your FDA Food Facility contact Quality Smart Solutions for assistance. The biennial renewal period is every other year during the period beginning on October 1 and ending on December 31 of each even-numbered year.

What do I need to know about the FDA Food Facility Renewals & Registration process?

Registering a food facility with the FDA seems to be simple, but it can sometimes be a confusing and lengthy process. At Quality Smart Solutions, we are committed to offering a full range of FDA Food Facility Registration/Renewal consulting services to domestic and foreign establishments. Our US compliance experts will also guide you with regard to paperwork and qualifications to move you quickly and efficiently through the registration or renewal process.

  • DUNS Request
  • Filing Online Application 
  • US Agent Appointment Authorization
  • Submission of Application for FDA Registration
  • Obtaining a Food Facility Registration Number
  • Receipt of Registration Certificate from US Agent

DUNS Requirement for 2022 Food Facility Registrations:

In October 2020, the Food and Drug Administration (FDA) released the requirement for all food facility registrations to include a UFI (Unique Facility Identifier). Currently, FDA has only approved Data Universal Numbering Systems (DUNS) numbers for use as UFIs for food facility registration.  Between October 1 and December 31 of this year, all FDA-registered facilities, must renew their registrations.

In March of 2021, FDA extended the deadline for food facility DUNS compliance to December 31, 2022, but it’s unlikely that it’s extended any further. If you have not registered for DUNS numbers for your food facility yet, obtaining a DUNS number should be a priority ahead of this upcoming FDA food renewal season. Your FDA facility registration information must line up with the information associated with the DUNS number.

Why is FDA Drug Registration & Renewal Essential?

Any United States-operated or foreign company that manufactures, repackages, or re-labels drug products to be sold in the U.S. must register with the FDA. The Drug Registration and Listing System (DRLS or eDRLS) is used to list each drug manufactured at these facilities for commercial distribution. The updated drug listing information needs to be submitted to the FDA twice per year in June and December.

Information Required for Drug Facility Registration

The below information is required by the FDA to meet the Drug Facility Registration requirements.

  • Name of the company/facility/establishment
  • Address of manufacturing /Processing /Packaging /Testing Facility
  • DUNS number for the establishment
  • Telephone, email, and name of the contact person
  • US Agent information for foreign companies
  • Business operation information

Do you need FDA Facility Registration or Renewal help for your U.S/foreign site?

Remember that Drug Facility Registration and FDA approval are two different aspects.

  • Registration is a mandatory requirement for manufacturing, testing, process, and packing facilities
  • FDA approval is required before a drug is imported into the U.S

FDA Drug Registration and Data Collection:

The drug registration and data are submitted electronically (eDRLS) using structured product labeling (SPL) format. This ensures that the agency has a list of all the drug manufacturers producing drugs for sale in the U.S. and a current inventory of U.S. supply chain drugs. Portions of the data are published in the FDA National Drug Code Directory, FDA label repository, FDA drug establishment current registration site, and NIH’s DailyMed. Having the data accurate and up to date is essential for promoting patient safety and is relied upon for several key establishment registration and drug listing programs such as:

  • Drug establishment inspections
  • Post-market surveillance
  • Counterterrorism
  • Recalls
  • Drug quality reports
  • Adverse event reports
  • Monitoring of drug shortages and availability
  • Supply chain security
  • Drug import and export
  • Identification of products that are marketed without an approved application

Registration renewal occurs between October 1 and December 31 each year, while listing updates may occur at any time in the calendar year.

Why is FDA Medical Device Registration and Renewal Mandatory?

Anyone who owns an establishment or facility that produces and distributes medical devices in the U.S. must register (Establishment Registration) each year with the FDA. Most of these establishments are also required to list the devices made at the facility and activities performed with them. Depending on the type of activity that is being performed a registration fee may be applied to your facility registration.  Failure to do this results in delay or refusal of medical devices. Registering establishments or facilities with FDA is known as establishment registration.

Our team of experts can help with your FDA establishment registration for medical devices. The registration of a medical device establishment is a two-step process. First, you must pay the annual registration user fee. Once you have paid the fee, the registration process can be finalized.

Medical Devices that require a premarket submission:

If a premarket submission is required for the medical device before advertising it in the U.S then the owner should provide the FDA premarket submission number (510(k), De Novo, PMA, PDP, HDE) as part of the establishment registration. The registration and listing information needs to be submitted electronically. This information is essential to increasing the United States’ response and preparation for public health emergencies.

The FDA Establishment Registration renewal is due each year between October 1st and December 31st.

How Quality Smart Solutions can help

We can guide you through the entire FDA Facility Registration or FDA Facility Renewal process for domestic and foreign Food, Medical Devices, and Drug facilities

We’re here to serve your regulatory needs, so please reach out to us at info@qualitysmartsolutions.com with any regulatory questions.

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