Medical Device Listing and Establishment Registration

Simplify Your FDA Device Registration and Listing

We help medical device manufacturers ensure that they meet the FDA requirements in listing and registration of a device, and thus properly list their devices and have their establishments registered to get into the market.

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Before a medical device can be sold in the U.S., manufacturers and certain other parties must register their establishment with the FDA and list their devices. Our Medical Device Listing & Registration service takes the guesswork out of this mandatory process. ADBC CRO helps you understand who needs to register and list, complete the FDA’s registration (FURLS) steps correctly, and maintain compliance annually (including managing the required FDA fee). Whether you’re a domestic startup or a foreign manufacturer needing a U.S. Agent, we ensure your FDA registration and device listing are done right, preventing costly import delays or legal issues so you can enter the U.S. market smoothly.

Our Services Include

FDA Medical Device Establishment Registration Basics Explains what FDA establishment registration is and why it’s required. Outlines the fundamentals of registering a medical device company/facility with FDA, clarifying that it’s an annual obligation and separate from product approval. Good primer on the purpose and process of registration, and how it fits into overall FDA compliance.

Who Must Register and List Medical Devices with the FDA? Details which types of companies are required to register and list. Covers manufacturers (including contract manufacturers and specification developers), initial importers, repackagers/relabelers, etc., and notes any exemptions. Helps readers determine if the FDA rules apply to their business and devices.

How to Register a Medical Device Establishment – Step-by-Step Guide Walks through the process of actually registering a device establishment with FDA. Includes steps like paying the annual registration user fee, creating an account in FDA’s FURLS system, submitting establishment information, and receiving a registration number. Provides practical guidance to complete registration without errors.

FDA Establishment Registration Annual Fee & Renewal Discusses the yearly fee that FDA charges for device establishment registration and the timeline for renewal. Explains when and how to pay the fee each fiscal year (Oct 1 – Dec 31 window), and emphasizes the importance of renewing on time every year to keep your registration active (and the consequences if you don’t).

FDA Device Listing Requirements & Product Codes Explained Focuses on the device listing part of “registration and listing.” Describes what information companies must provide about each device (like the device name, product code, and regulatory class) and how to find the correct FDA product code/classification for a device. Also covers the need to update listings when you introduce new devices or make changes, to ensure FDA’s database stays accurate.

Updating FDA Registration – Ownership or Address Changes, New Devices, etc. Explains how to update your FDA establishment registration when key details change. For instance, if your company moves to a new address, changes name or ownership, or if you start manufacturing additional devices. Covers how to handle these updates in FDA’s system and the required timeframes, so your registration remains up-to-date and in compliance.

FDA Foreign Medical Device Registration & U.S. Agent Requirements Special guidance for foreign manufacturers exporting devices to the U.S. Discusses the extra steps they must take: designating a U.S. Agent for FDA communications, understanding the role of the U.S. Agent, and any unique considerations for foreign establishments (like having an Importer of Record). Ensures non-U.S. companies know how to fulfill all FDA requirements to legally import their devices.

Consequences of Failing to Register or List Your Medical Device Outlines what can happen if a company does not properly register or list. For example, devices are considered misbranded by law if made in an unregistered facility, which can lead to FDA enforcement. Talks about potential consequences like import detentions (FDA refusing entry of the products), warning letters, or other penalties, highlighting why registration/listing compliance is critical.

Case Studies: FDA Registration Issues Causing Import Delays and Holds Real-life scenarios where companies ran into trouble due to registration or listing mistakes. For instance, a case where a shipment was held because the manufacturer wasn’t registered or a device wasn’t listed. These case studies illustrate the practical impacts (lost time, money, and product spoilage risk) and reinforce the importance of getting registration right.

Best Practices for Smooth FDA Registration and Device Listing A collection of tips and best practices to make the registration and listing process go smoothly. Suggestions might include keeping thorough records, double-checking information before submission, setting calendar reminders for annual renewals, using FDA’s guidance documents, and conducting internal audits of your registration/listing status. Aimed at helping companies maintain compliance year after year with minimal hassle.

Contact us for medical device listing and FDA registration services!

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