FDA Medical Device Registration and Approval

FDA registration for medical devices

For medical devices, the Food and Drug Administration operates a classification system that covers around 1,700 generic device types grouped into 16 medical specialty panels. Each device type is assigned to one of three regulatory classes based on the level of control needed to provide reasonable assurance of the device's safety and effectiveness.

Device classes and their controls

• Class I: General Controls
• Class II: General Controls and Special Controls
• Class III: General Controls and Premarket Approval

The Federal Food, Drug, and Cosmetic Act defines a medical device as an instrument, apparatus, implement, machine, contrivance, or any component, part, or accessory, and includes the following categories:

• Defined in the official National Formulary or the United States Pharmacopeia, or any supplement to them.
• Intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals.
• Intended to affect the structure or any function of the human or animal body and that does not achieve its primary intended purposes through chemical action within or on the human or animal body and is not dependent upon being metabolised to achieve those purposes.

How Sistem Patent Kalite supports medical device registration

Sistem Patent Kalite supports device classification, registration listings, 510(k) submissions where applicable, and the US Agent appointment for foreign manufacturers. Clients receive a clear roadmap for their specific device class, which sets expectations on the evidence needed and the time the FDA will take to clear the submission.