For businesses involved in the production or distribution of medical devices in the United States, ensuring compliance with the FDA’s registration and listing requirements is essential. In this article, UCC will provide an overview of the process, with a particular focus on the FDA product code list for medical devices and how to properly list your devices with the FDA.
1. Overview of FDA Product Code List for Medical Devices
Most establishments that deal with medical devices and are required to register with the FDA must notify the agency about the devices they are distributing, including those manufactured solely for export. Additionally, this process is known as medical device listing, which ensures the FDA stays informed about the types of devices these establishments manufacture or market. Moreover, every year, companies that have registered must renew their registration with the FDA by December 31.
Companies that manufacture or distribute medical devices in the United States need to adhere to several FDA requirements. These include registering their facility with the FDA, listing their devices according to the appropriate categories, and, if they are foreign companies, designating a US Agent to facilitate communication and compliance.
2. Who Needs to Register on the FDA Product Code List for Medical Devices?
Any establishment involved in manufacturing, preparing, assembling, or handling medical devices for commercial distribution in the United States must list their devices with the FDA. Moreover, this must be done within 30 days of distributing them. Furthermore, the Product Code List for Medical Devices requirement applies to:
- Manufacturers
- Repackagers and relabelers
- Specification developers
- Remanufacturers of single-use devices
- Remanufacturers
- “Export-only” manufacturers in the U.S.
- Manufacturers of accessories and components intended for health-related purposes
Foreign manufacturers and exporters must list their devices before importing them into the U.S. Additionally, contract manufacturers and contract sterilizers need to register their facilities and list their devices if they are distributing them.
3. How to List Medical Devices Using the FDA Product Code List
3.1. Identify the Medical Device Classification under the FDA
The FDA classifies medical devices into three categories (Class I, II, III) based on their risk level and intended use:
- Class I: Low-risk devices (e.g., bandages), usually exempt from premarket notification.
- Class II: Moderate-risk devices (e.g., infusion pumps), generally requiring 510(k) submission.
- Class III: High-risk devices (e.g., implantable defibrillators) that require premarket approval (PMA).
Use the FDA’s Product Classification Database to determine your device’s classification and regulatory requirements.
3.2. Complete Your FDA Facility Registration
Manufacturers and those involved in medical device production or distribution must annually register their facilities with the FDA. Specifically, this process is managed through the FDA’s Unified Registration and Listing System (FURLS). Additionally, during this step, you will need to pay an annual registration fee. This is a mandatory step if you want to be included in the FDA Product Code List for Medical Devices.
Action: Register through the FDA Industry Systems (FIS).
3.3. Submit Premarket Notification (If Required)
- 510(k): Demonstrates your device is “substantially equivalent” to one already on the market.
- PMA: Required for new, high-risk devices.
- De Novo: For new devices without a predicate and lower to moderate risk.
Determine whether your device requires premarket submission and prepare the necessary documentation. This is an important step to list on the FDA Product Code List for Medical Devices
3.4. Comply with Labeling and UDI Requirements
Ensure your labeling meets the FDA’s regulations (21 CFR Part 801). Additionally, if applicable, include the medical device unique identifier (UDI) to facilitate device traceability.
3.5. Complete the Device Listing Process
Having registered your facility and submitted the required documents, you must then list your devices in the FDA database. To accomplish this, log into FURLS and provide detailed information about each device, including its trade name, product code, and intended use. Furthermore, make sure all details are accurate to ensure compliance with FDA regulations.
3.6. Stay Informed of FDA Regulatory Changes
Regularly check for FDA updates to maintain compliance with evolving standards.
Navigating the FDA’s registration and FDA Product Code List for Medical Devices, along with the proper implementation of the medical device unique identifier (UDI), can be complex. Therefore, if you have specific questions or need expert guidance, feel free to contact UCC for assistance in simplifying this process and ensuring full compliance with FDA regulations.
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