Who is required to register medical devices with the FDA?
Domestic and foreign establishments that manufacture, contract-manufacture, sterilize, repackage, relabel, remanufacture, or initially import medical devices for U.S. commercial distribution generally must register annually with the FDA. Most registered establishments must also list the devices and activities associated with the facility.
Answer
FDA medical-device registration applies to establishments based on the activities they perform, not simply the company’s ownership or location.
Establishments commonly required to register include:
• Finished-device manufacturers and kit assemblers
• Contract manufacturers and contract packagers
• Contract sterilizers
• Specification developers
• Repackagers and relabelers
• Remanufacturers
• Reprocessors of single-use devices
• Initial importers located in the United States
• Foreign manufacturers and qualifying foreign exporters
• Manufacturers of custom or export-only devices
Most of these establishments must also list their devices and pay the annual establishment-registration fee. An initial importer registers and identifies the foreign manufacturers and devices it imports but ordinarily does not create the manufacturer’s device listing. Foreign establishments must designate a U.S. agent, although acting solely as a U.S. agent does not itself create a registration obligation.
Registration responsibilities can change when a company performs multiple activities. For example, a distributor that applies new labeling may become a relabeler, while a brand owner that develops device specifications and arranges contract manufacturing may qualify as a specification developer.
FDA’s registration requirements table should be checked against each establishment’s activities. Registration and listing do not represent FDA clearance, approval, certification, or endorsement.
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