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.  We’ll outline to difficulties of this process and explain why it is mandatory for each industry.

How long does FDA Facility Registration take?

  

The time it takes to complete FDA Facility Registration can vary based on several factors, including the type of medical devices being manufactured, the accuracy and completeness of the information provided, the responsiveness of the facility to any requests for additional information, and the overall workload of the FDA at the time of submission. As a result, there is no fixed duration for the facility registration process. However, I can provide you with a general idea of the timeline involved:

  1. Submission Time: The actual time it takes to complete the submission of the FDA Facility Registration information through the Electronic Registration and Listing System (eRLS) can range from a few hours to several days, depending on the complexity of the information being entered and the familiarity of the applicant with the process.

  2. Review and Processing Time: After submission, the FDA will review the registration information. This review process can take several weeks to a few months, depending on the workload of the FDA and the specific details of the facility and devices being registered.

  3. Communication and Clarifications: If the FDA identifies any issues, discrepancies, or requires additional information during the review process, they may contact the facility for clarification or additional documentation. The time it takes to respond to such requests can influence the overall registration timeline.

  4. Approval and Issuance of FEI: Once the FDA is satisfied with the registration information and any necessary clarifications have been provided, they will issue an Establishment Identifier (FEI) to the facility. This process may take several weeks to finalize.

  5. Routine Inspections (if applicable): Registered facilities are subject to routine inspections by the FDA to ensure compliance with regulatory requirements. The scheduling and completion of inspections can also impact the overall timeline.

It’s important to plan ahead and initiate the facility registration process well in advance of any anticipated marketing or distribution activities. Regulatory experts and consultants may be able to provide guidance and help expedite the process. Additionally, staying informed about FDA guidance and any updates to the registration process can help ensure a smoother and more efficient registration experience.

Why is FDA Facility Registration difficult?
 

Registering a facility with the U.S. Food and Drug Administration (FDA) can sometimes be perceived as difficult due to several reasons:

  1. Complex Regulatory Environment: The FDA operates within a complex regulatory framework with specific requirements and standards for various industries, including pharmaceuticals, medical devices, food, cosmetics, and more. Navigating and understanding these regulations can be challenging, especially for individuals who are not familiar with the regulatory landscape.

  2. Varied Requirements: Different types of facilities have different registration requirements and processes. The information and documentation needed for facility registration can vary widely based on the nature of the products being manufactured or handled, the facility’s location, and its role in the supply chain.

  3. Stringent Quality Standards: FDA regulations emphasize safety, quality, and efficacy of products that enter the market. Facilities seeking FDA registration must adhere to strict quality standards, which can involve implementing detailed quality management systems, maintaining proper documentation, and demonstrating compliance with Good Manufacturing Practices (GMP) or other relevant regulations.

  4. Documentation and Record Keeping: The FDA requires comprehensive documentation and record-keeping practices to ensure traceability and accountability throughout the product lifecycle. Preparing and maintaining accurate records can be time-consuming and may require meticulous attention to detail.

  5. Specific Technical Knowledge: Facility registration often involves technical aspects related to manufacturing processes, quality control, labeling, and more. Having the necessary technical knowledge and expertise is essential to accurately complete the registration process.

  6. Language and Terminology: The terminology used in FDA regulations can be complex and specialized. Understanding and correctly interpreting these terms is important for accurately completing the registration process.

  7. Risk Mitigation and Compliance: The FDA places a strong emphasis on risk mitigation and compliance with regulations to protect public health. Facilities must demonstrate their ability to identify and mitigate potential risks associated with their products and processes.

  8. Time and Resource Commitment: The facility registration process may require a significant investment of time, effort, and resources to compile and submit the necessary information and documentation. This can be especially challenging for smaller companies or facilities with limited resources.

  9. Potential Consequences of Errors: Mistakes or omissions in the registration process can lead to delays, rejections, or regulatory actions from the FDA. Ensuring accuracy and completeness is crucial to avoid potential negative outcomes.

While the FDA facility registration process may be perceived as difficult, it’s important to note that it is designed to uphold high standards of safety and quality for products entering the market. Seeking guidance from regulatory experts, consulting FDA guidance documents, and staying informed about regulatory changes can help streamline the process and ensure successful facility registration.

What are the benefits of FDA Facility Registration?

 

FDA facility registration offers several benefits to manufacturers, distributors, and other entities involved in the production, distribution, or importation of regulated products. Registering a facility with the U.S. Food and Drug Administration (FDA) is a requirement for many industries, and it serves to ensure the safety, quality, and effectiveness of products that enter the market. Here are some key benefits of FDA facility registration:

  1. Legal Requirement: In many cases, FDA facility registration is a legal requirement for companies that manufacture, process, pack, or hold regulated products, including pharmaceuticals, medical devices, biologics, food, cosmetics, and more. Compliance with this requirement helps companies avoid potential legal and regulatory penalties.

  2. Market Access: FDA registration is often a prerequisite for companies seeking to market their products in the United States. Without proper facility registration, companies may not be allowed to distribute or sell their products within the U.S. market.

  3. Supply Chain Integrity: Facility registration enhances transparency and traceability within the supply chain. It helps ensure that products are produced, handled, and distributed by facilities that meet FDA’s regulatory standards for safety, quality, and good manufacturing practices.

  4. Public Health and Safety: FDA facility registration is a critical component of the agency’s efforts to protect public health. It allows the FDA to monitor and inspect facilities to ensure that they are compliant with relevant regulations and that products are safe and effective for consumers.

  5. Product Quality: Facility registration is often tied to adherence to Good Manufacturing Practices (GMP) or other quality standards. Registered facilities are expected to maintain high levels of product quality, which contributes to the overall safety and effectiveness of regulated products.

  6. Consumer Confidence: Registered facilities are subject to regulatory oversight and inspections by the FDA. This oversight helps build consumer confidence in the safety and quality of the products they purchase.

  7. Regulatory Compliance: Facility registration demonstrates a commitment to regulatory compliance. Registered facilities are more likely to be aware of and follow FDA regulations, which helps them avoid compliance issues and regulatory actions.

  8. Global Trade: For companies engaged in international trade, FDA registration may be required to meet the regulatory requirements of other countries or to participate in global supply chains.

  9. Research and Innovation: FDA registration is important for companies involved in research, development, and innovation within the regulated industries. Registered facilities are more likely to have access to regulatory guidance and support as they work on new products and technologies.

  10. Access to Resources: Registered facilities may have access to FDA guidance documents, updates on regulatory changes, and educational materials to help them stay informed and compliant with evolving regulations.

It’s important to note that the benefits of FDA facility registration go beyond just meeting regulatory obligations. Registration contributes to the overall integrity and credibility of the regulated industries and helps ensure that products reaching consumers are safe, effective, and of high quality.

Why is Food FDA 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 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. Click here for a free guide to Drug Facility Registration.

  • 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 the 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.

What is required to register a medical device manufacturing facility with the FDA?

  

Registering a medical device manufacturing facility with the U.S. Food and Drug Administration (FDA) involves several steps and requirements to ensure that the facility complies with regulatory standards and can produce safe and effective medical devices. The specific requirements can vary based on the type of facility and the classification of the devices being manufactured. Here is an overview of the general requirements for registering a medical device manufacturing facility with the FDA:

1. Determine Registration and Listing Requirements:

  • Identify the correct registration and listing requirements based on the type of medical devices being manufactured. The FDA assigns a unique Establishment Identifier (FEI) to each registered facility.

2. Create or Update an FDA Account:

  • If you don’t already have an FDA Industry Systems (FIS) account, create one on the FDA Unified Registration and Listing Systems (FURLS) website.

3. Access the Electronic Registration and Listing System:

  • Log in to the FDA Electronic Registration and Listing System (eRLS) using your FIS account.

4. Complete Facility Registration:

  • Provide detailed information about the manufacturing facility, including its location, contact details, ownership, and operational details.

5. Determine Device Listing:

  • Identify the specific medical devices that are being manufactured at the facility. These devices should be appropriately classified under the FDA’s medical device classification system.

6. Provide Device Information:

  • For each listed medical device, provide relevant information such as device classification, intended use, product code, and manufacturing processes.

7. Pay Registration Fees (if applicable):

  • Some facilities may be required to pay registration fees based on the type and size of the establishment.

8. Submit the Registration and Listing Information:

  • Review and submit the registration and listing information through the eRLS system.

9. Obtain Establishment Identifier (FEI):

  • After successful submission, you will receive an Establishment Identifier (FEI) for the facility. This unique identifier is used to track and identify the facility in FDA records.

10. Maintain Registration:

  • Keep the facility’s registration and listing information up to date by submitting any necessary updates or changes to the FDA.

11. Prepare for Inspections:

  • Registered facilities are subject to routine inspections by the FDA to ensure compliance with regulatory requirements. Prepare for inspections by maintaining proper documentation and adhering to Good Manufacturing Practices (GMP) or relevant quality standards.

It’s important to note that the above steps provide a general overview of the registration process. The specific requirements and procedures may vary based on factors such as the type of devices being manufactured, the facility’s location, and the applicable regulations. Manufacturers should carefully review FDA guidance documents, consult with regulatory experts, and stay informed about any updates or changes to the registration process.

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