FDA medical device listing: is it mandatory?
Legal background
FDA establishment registration and device listing is a legal requirement under 21 CFR Part 807. FDA product listing confirms that your medical device is actively marketed and compliant. Without it, your device cannot be legally sold in the United States.
Accurate listing ensures:
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- Your product is recognized and trackable by the FDA
- Smooth customs clearance and reduced risk of shipment holds
- Faster response to inspections, audits, or recalls
- Increased trust and visibility with U.S. distributors and partners
Our services
FDA Device Registration and Listing Services for Medical Devices by Obelis
As your Official FDA Correspondent, Obelis handles the entire Device Listing process on your behalf. We submit your product information via the FDA’s FURLS system, ensure accurate product codes and device classification, manage your annual FDA medical device listing renewal, and maintain compliance with FDA updates. With Obelis as your trusted regulatory partner, you reduce compliance risks and ensure your medical device is properly listed and visible in the FDA database.
Contact Obelis to secure your FDA device registration and listing and ensure your medical device remains compliant and competitive in the U.S. market.
FAQ
Frequently Asked Questions
You can find your FDA medical device listing number by searching the FDA’s public Establishment Registration & Device Listing database. This search will show the device name, product code, and registration details. If you work with Obelis, we can provide you with your listing number and ensure it is always up to date.
FDA device registration refers to registering your company or establishment with the FDA, while FDA device listing involves submitting detailed information about each specific medical device you market in the U.S. Both steps are required for compliance.
FDA device listings must be reviewed and updated annually, even if no changes have occurred. Any modifications to your device information, such as name, classification, or product code, must be reported promptly to maintain compliance and avoid regulatory issues.
If your FDA device listing is inaccurate or expires, your product may be subject to entry refusals, customs holds, or removal from the U.S. market. Working with a regulatory partner like Obelis ensures your listing remains accurate, current, and fully compliant with FDA requirements.
As your Official FDA Correspondent, Obelis manages the full FDA device registration and listing process, including submission through FURLS, annual renewals, and ensuring accurate product codes and classifications. We help you avoid delays, reduce compliance risks, and keep your device visible in the FDA database.
