Registration & Licensing for Foreign Device Manufacturers
The medical device industry is witnessing rapid growth, and with it comes the need for foreign manufacturers to navigate the complex landscape of licensing and registration requirements in the United States. As a foreign device manufacturer, understanding the intricacies of the licensing and registration process is crucial for successful market entry and compliance with regulatory authorities like the US Food and Drug Administration (FDA) and state boards of pharmacy.
This guide aims to provide a comprehensive overview of licensing and registration for foreign medical device manufacturers in the United States, covering important aspects such as device approval, device listing, establishment registration, and compliance with state licensing regulations.
Understanding the FDA's Role in Regulating Foreign Establishments
The FDA plays a pivotal role in regulating medical devices in the United States. Medical device manufacturers planning to launch their products in the United States market must navigate the regulatory requirements set by the FDA. As a foreign manufacturer, it is essential to familiarize yourself with the FDA's requirements to ensure compliance.
FDA requires foreign medical device manufacturers planning to market in the US to obtain FDA clearance for devices they manufacture. Foreign medical device manufacturers must also register their establishments and list their devices with the agency. Let's delve deeper into these key FDA components.
FDA Medical Device Clearance
FDA clearance is a crucial step in ensuring the safety and effectiveness of medical devices. The FDA offers two primary pathways for clearance: Premarket Notification (510(k)) and Premarket Approval (PMA). Understanding the difference between these two processes and determining the appropriate pathway for a finished device is essential for a successful FDA submission.
The 510(k) Submission Process for Medical Devices
The 510(k) submission process is required to obtain FDA clearance for most moderate-risk (Class II) medical devices. The purpose of a 510(k) submission is to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This means proving that the new device has similar intended use, indications for use, and technological characteristics as the predicate device.
The 510(k) submission typically includes information such as device characteristics, intended use, indications for use, and design verification. The FDA reviews 510(k) submissions, and if accepted, the submission is posted to the FDA 510(k) database. It's important to note that a successful 510(k) submission results in FDA clearance, not FDA approval.
The PMA Submission Process for Medical Devices
Medical devices considered high-risk (Class III) require a PMA submission for FDA approval before they can be marketed in the United States. The PMA submission process is more rigorous and extensive compared to the 510(k) process. It involves providing evidence of the finished device's safety and effectiveness through clinical trials with human participants, as well as laboratory testing.
The PMA submission must include administrative elements and scientific and clinical data for review and approval by the FDA. The FDA has 180 days to accept or reject the PMA application. Class III devices are considered critical to patients' health and require the highest level of scrutiny due to their potential risks.
Medical Device FDA Establishment Registration for Foreign Device Manufactures
Foreign owners and operators of establishments that are involved in the production of medical devices intended for use in the United States must register their establishments annually with the FDA. This process is known as establishment registration and is required under Title 21 CFR Part 807. Registration of establishments helps the FDA maintain a comprehensive database of all medical device manufacturers that produce medical devices intended for use in the US.
Importance of FDA Registration for Foreign Establishments
FDA Establishment Registration serves as a means to track and monitor medical device manufacturers, ensuring compliance with regulatory standards. Identifying where devices are produced increases the nation's ability to prepare for and respond to public health emergencies. Medical device establishment registration is a separate process from obtaining specific clearances or approvals such as the 510(k) clearance or PMA previously discussed.
Steps to Complete FDA Establishment Registration
Completing the FDA Establishment Registration process involves several key steps.
Step 1: Payment of Annual Registration User Fee
The first step in the medical device establishment registration process is to pay the annual establishment user registration fee. The FDA collects annual facility registration user fees, which vary from year to year. For Fiscal Year 2024, the fee is $7,653. Once payment is made, a Payment Identification Number (PIN) and the Payment Confirmation Number (PCN) will be issued for use in the registration process.
Step 2: Account Setup in the FDA FURLS System
Once the establishment user fee has been paid, establishments must complete the registration and listing information. Federal law requires that all registration and listing information be submitted electronically unless FDA grants a waiver. For companies new to the US market, an account must be set up in the FDA’s Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM) system. This account will serve as the platform for managing the establishment registration.
Step 3: Completing Facility Registration Details
The next step is to provide all necessary details about your facility on the registration form. This information includes your company name, address, contact information, and other relevant details.
Step 4: Listing Medical Devices
In addition to the medical device establishment registration, FDA requires registered establishments to list the devices they manufacture, process, distribute, or import. Device listing is a critical step that allows the FDA to maintain an accurate inventory of medical devices available in the market. This register list is crucial for regulatory oversight, post-market surveillance, and effective management of recalls or safety alerts.
Device listing involves providing detailed descriptions of the devices, including their intended use, classification, and any necessary regulatory clearances.
It is important to ensure that the device listing is kept up to date and accurate, reflecting any changes or additions to the manufacturer's product portfolio.
Step 5: Certify and Submit Registration
Once devices are listed, the user must certify that all the information is correct and submit. Once submitted, the user will be prompted to enter both the PIN and PCN numbers issued during the payment process. A confirmation screen will be displayed and the establishment is considered registered. Upon submission, the FDA will assign a unique establishment registration number, also known as an FDA Establishment Identifier or FEI, which serves as a crucial identifier moving forward.
Renewal of FDA Establishment Registration
It is important to note that the FDA Establishment Registration must be renewed annually. This renewal process involves verifying and updating the registration and licensing information between October 1st and December 31st of each year.
State Licensing for Foreign Device Manufacturers
Foreign device manufacturers often encounter various challenges when navigating state licensing requirements in the United States. While the FDA oversees the federal regulations, individual states may have their own set of medical device licensing requirements. This can create a complex and confusing array of laws and regulations for foreign manufacturers to navigate. Let's explore the state licensing landscape and how foreign manufacturers can address these challenges.
State Licensing Requirements for Foreign Establishments
Currently, more than 20 states in the United States currently require some form of licensure or permit for medical device manufacturers and distributors. With no standard set of requirements across the states, foreign manufacturers are left to to navigate individual state laws and regulations to understand each state licensing requirement.
Some states, such as California, require a state license for medical device manufacturers, but only if the manufacturer is physically located in the state. Further, based on the state’s definition of device, not all medical devices as defined by FDA regulations may be regulated by the state for distribution.
Specific to foreign manufacturers, some states that regulate medical device manufacturers, such as Idaho, do not regulate foreign manufacturers. Other states, such as Connecticut, regulate foreign medical device manufacturers.
The Benefits of Partnering with Compliance Experts
Navigating the varied state licensing requirements can be a daunting task for foreign manufacturers. Engaging a compliance partner with expertise in medical device state regulations can simplify the process and clarify state licensing obligations. Compliance experts stay up to date with the ever-evolving regulatory landscape, enabling manufacturers to focus on their core competencies while ensuring compliance with state-specific requirements.
Complete Compliance Solutions partners with medical device manufacturers to guide them through the licensing requirements for each state their device is distributed or sold into, helping them avoid launch delays and potential compliance issues. Contact us today.
Medical Device Reporting Requirements in the United States
In addition to medical device facility registration and licensing requirements, foreign medical device manufacturers are required to comply with ongoing Medical Device Reporting (MDR) requirements under Title 21 CFR Part 803. MDR is a postmarket surveillance tool used by the FDA to monitor the performance of medical devices and detect potential safety issues. It involves the reporting of adverse events, serious injuries, and malfunctions associated with medical devices. The information obtained through MDR helps the FDA assess the risks and benefits of medical devices, ensuring their safety and effectiveness for patients.
Foreign medical device manufacturers who distribute their devices in the United States are required to designate a US agent. As part of the US agent’s responsibilities, the agent is required to forward MDR complaints to the foreign manufacturer and maintain required documentation of the event. The agent must collect necessary information from the foreign manufacturer for the investigation and evaluation of the adverse event.
Mandatory reporters must follow specific processes outlined by the FDA for reporting medical device adverse events. Information and instructions for mandatory device reporting can be found on the FDA's website.
Navigating the requirements for registration and licensing for foreign medical device manufacturers in the United States is a complex task. Understanding compliance with regulatory obligations related to device clearance and listing, establishment registration and state-specific licensing requirements is crucial for successful market entry. By partnering with compliance experts, foreign manufacturers can navigate the intricate regulatory landscape with confidence and ensure compliance with both federal and state regulations. With the right guidance and support, foreign manufacturers can establish a strong foothold in the United States' lucrative medical device market.
Contact us today to learn how Complete Compliance Solutions can support your state medical device licensing needs.
Author: Maureen May
Disclaimer: The information provided in this article is for informational purposes only and should not be considered legal or regulatory advice. Manufacturers should consult with legal and regulatory professionals to ensure compliance with all applicable laws and regulations.