Who is exempt from FDA registration?

Several establishment types may be exempt from FDA medical-device registration and listing.

Common examples include:
• Domestic distributors that do not import devices
• Wholesale distributors that are neither manufacturers nor initial importers
• Import brokers or agents that do not take first possession
• Manufacturers of components supplied only to finished-device manufacturers, when the component is not separately distributed as a finished device
• Specification consultants that provide advice but do not act as specification developers
• Refurbishers or remarketers of used devices that do not significantly change device performance, safety specifications, or intended use
• Establishments handling only investigational devices under an applicable Investigational Device Exemption
• Certain healthcare practitioners, pharmacies, and other operations covered by specific statutory or regulatory exemptions

An exempt establishment may lose that status if its activities change. A component manufacturer can become registrable if the component is packaged or labeled for direct health-related use by an end user. A refurbisher may become a remanufacturer if its work significantly changes performance, safety specifications, or intended use. A distributor may become an initial importer, relabeler, or specification developer.

Registration exemption also does not remove other legal responsibilities. Applicable requirements may still include labeling controls, complaint handling, Medical Device Reporting, corrections and removals, product-specific controls, or state licensing. FDA’s activity-based registration table should therefore be reviewed before relying on an exemption.