FDA Establishment Registration and Device Listing

Medical device manufacturers and distributors aiming to market their products in the United States through 510(k) submission must comply with stringent regulations established by the U.S. Food and Drug Administration (FDA) including FDA Establishment Registration and device listing.

These processes ensure that medical device facilities and their products meet the safety and efficacy standards required to protect public health.

Establishment Registration is an annual process where medical devices facilities intend to market their medical devices within the U.S must register with the FDA.

By registering, these facilities declare their compliance with FDA regulations, ensuring accountability and oversight. Most establishments that are required to register must also list their devices and the activities conducted on those devices at the establishment.

Device Listing involves submitting details about the medical devices manufactured or distributed by a registered facility. This process enables the FDA to track medical devices in the U.S. market.

All device listing information must be submitted electronically unless a specific waiver has been granted by the FDA.

If a device requires a premarket submission before it can be marketed in the U.S., the owner/operator must also provide the FDA premarket submission number (e.g., 510(k), De Novo, PMA, PDP, or HDE).

As outlined in Title 21 CFR Part 807, the following types of Medical device establishments can apply for Establishment Registration and Device Listing:

Owners of Domestic Establishments

  • Owners of Foreign Establishments
  • Contract Manufacturers & sterilizers
  • Initial Importers
  • Re-packers / Re-labelers
  • Foreign exporters
  • Remanufacturers
  • Re-processors
  • Specification Developers
  • U. S. manufacturers of export only devices

Steps to Register an Establishment and List Devices

To streamline the registration and listing processes, the FDA has outlined a series of steps that facilities must follow. These steps are detailed below:

Step 1: Access the FDA Registration Website

  • Visit the FDA Device Facility User Fee website and pay the required annual fee for fiscal year 2025 ( October 1, 2024- September 30, 2025), the fee is $9,280.
  • Note: The fee is uniform for all establishments, regardless of size or device production volume. Notably, waivers or reductions are not available for small businesses in FY 2025.
  • After payment, obtain the Payment Identification Number (PIN) and Payment Confirmation Number (PCN).
  • Next, access the FDA Unified Registration and Listing System (FURLS) through the FDA Access Portal.
  • If a new user, an account must be created; otherwise, an existing account should be logged into.
  • Navigate to the Device Registration and Listing Module (DRLM) to proceed.

Step 2: Register the facility

  • For new facilities, “Register a New medical device Facility” should be selected from the DRLM menu.
  • Details such as the facility type (manufacturer, importer, or distributor), associated devices, and whether the device requires 510(k) submission, or is 510(k) exempt must be provided.
  • Relevant information, such as proprietary names, product codes, and regulatory classifications, should also be included.
  • 510(k) submission numbers are required for cleared devices.
  • For annual registration, “Annual Registration” should be selected to review and update facility information, device listings, and importer or manufacturer details (for foreign establishments).

Step 3: Submit and Obtain the Certificate

  • All details, including establishment and device information, should be verified for accuracy.
  • The PIN and PCN obtained earlier must be entered, and the registration and device listing should be submitted.
  • Upon submission, a confirmation screen will display the successful completion of the process, and the FDA will consider the facility registered.
  • A unique FDA Establishment Identifier (FEI) will be assigned to the facility, serving as a regulatory reference.
  • A certificate of registration may also be issued through third-party firms, such as FDA Listing Inc.

Important Aspects of Establishment Registration and Device Listing

  1. Annual Renewal: Establishment Registration and listing must be renewed yearly between October 1 and December 31. Facilities must register within five days of starting operations. Ensure you complete the process before the start of the new fiscal year (October 1) to avoid lapses in compliance.
  2. Foreign Manufacturers: Non-U.S. manufacturers must designate a U.S. agent who will serve as their primary contact with the FDA. The contact details of the U.S. agent must be provided during the registration process.
  3. Electronic Submissions: All registration and listing information must be submitted electronically, except in cases where the FDA has granted a waiver.
  4. Payment Confirmation: The Payment Confirmation Number (PCN) and Payment Identification Number (PIN) should be retained for records, as they are required for successful registration and listing.

Conclusion

Establishment Registration and Device Listing are essential for marketing medical devices in the U.S. Following the outlined steps helps ensure compliance with FDA regulations, making product market within U.S. easier. Annual registration requires updating records, while initial registration involves creating a new facility profile. Staying informed and consulting experts can simplify the process and ensure success.

Author

Ruksana Sanafar

Sr. Consultant, FDA Compliance |Medical Device

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