U.S. FDA Medical Device Establishment Registration & Listing Requirements

Firms involved in manufacturing, packaging, labeling or reprocessing of devices must pay an annual fee. Many establishments that are required to register with the U.S. FDA also are required to list their devices.

The U.S. FDA is responsible for regulating firms who manufacture, repackage, re-label, and/or import medical devices sold in the United States. For devices that are exempt from Premarket Notification, Manufacturers (both domestic and non-U.S.) and initial distributors (importers) of medical devices must register their establishments with the U.S. FDA annually. All registration information must be verified annually between October 1st and December 31st of each year.

In addition to registration, foreign manufacturers must also designate a U.S. Agent. The new U.S. Food and Drug Administration Safety and Innovation Act (FDASIA) impose many Medical Device Establishment Registration and Listings requirements, effective October 1, 2012.

If you are not registered with U.S. FDA MEDERA Consulting can provide guidance on required elements, formats, and particularities of submissions, including:

  • Help determining whether registration exclusions apply and, if not, we will prepare and submit your registrations with U.S. FDA and make changes, updates and cancellations as needed.
  • • Assistance determining if U.S. FDA Medical Device User Fees are required for your registration and, if so, help prepare your payment as per U.S. FDA's requirements.

If you are already registered with the U.S. FDA the new U.S. Food and Drug Administration Safety and Innovation Act (FDASIA) requires companies to list new manufacturers, importers or proprietary names with their Medical Device Establishment Registration.

To find out more about marketing a therapeutic product in U.S., please click here to receive a copy of our free white paper. To find out more about using our Regulatory Affairs Services for Medical Devices, please contact us for more information.