What Is FDA Medical Device Establishment Registration?

FDA Medical Device Establishment Registration Registration of covered medical-device establishments with FDA. This process records an establishment with the U.S. Food and Drug Administration and associates its operations and device listings with FDA records so the agency can identify who is manufacturing, repackaging, relabeling, remanufacturing, or importing medical devices for commercial distribution in the United States.

The registration is a regulatory requirement under 21 CFR Part 807 and is separate from device marketing submissions such as 510(k), PMA, or De Novo. Registration captures establishment contact details, owner/operator information, and the types of device operations performed. The listing portion links specific device product codes and classifications back to the establishment, enabling regulatory oversight and inspection planning.

What The Registration Covers

The registration process and device listing together document the relationship between a physical site and the devices associated with it. Typical elements captured include the establishment name and address, owner/operator DUNS or FEI identifiers when applicable, the types of activities performed (e.g., manufacturing, sterilization, repackaging, relabeling), and the device product codes being distributed.

Why Registration Matters

Registration makes an establishment visible to FDA and is the first step in the agency’s ability to manage device risk in the supply chain. It enables FDA to:

• Identify Facilities: Know which firms and locations are involved in device manufacturing and distribution.
• Target Inspections: Prioritize inspections and surveillance based on reported devices and operations.
• Coordinate Recalls and Responses: Reach responsible parties quickly during safety actions or emergencies.

How The Process Works

Registration is performed electronically through the FDA Industry Systems (FIS) or FDA Unified Registration and Listing System (FURLS) account, depending on the current FDA portal in use. An account is created, the owner/operator identifies the establishments to register, and the firm submits information on device listings and activities. Annual renewal is required during the registration period (typically between October 1 and December 31 for most years) and updates must be submitted within 30 days of a change to registration information.

How It Varies By Operation Type

Not all activities trigger the same registration requirements. For example, manufacturers, repackers/relabelers, remanufacturers, and specification developers generally must register and list devices. Distributors who only warehousing and shipping may have different obligations. Importers bringing devices into the U.S. must register and list devices they distribute. The definition of a covered activity is detailed in 21 CFR Part 807.

Practical Example

A contract manufacturer in Ohio that assembles parts for an implantable device must register its establishment, list the device product code, and indicate the activities performed. A foreign manufacturer that imports devices through a U.S. importer will often have the importer register the importer establishment and list the device; the foreign establishment may also register depending on its U.S. business model and whether it holds an FDA Domestic Establishment Identification (FEI) through an agent.

Tips For Compliance

• Labeling Consistency: Ensure device listing names match the marketed device labeling to avoid confusion during inspection.
• Account Management: Maintain a single responsible person to manage FURLS/FIS credentials and registration renewals.
• Document Changes: Track facility changes (address, owner/operator) and submit updates within the FDA-required timeframes.

In short, the FDA Medical Device Establishment Registration records who is responsible for device operations in the U.S., links devices to their establishments, and forms the foundation for FDA's device oversight and response activities.