US · FDA

FDA pre-classification

Three questions, a transparent rule set and a likely class and pathway. Then confirm it in FDA’s own Product Classification Database.

Preliminary guidance only, not a regulatory determination. The binding classification comes from the FDA classification regulation for your device type.

1Is the device life-supporting or life-sustaining, implanted, or does it present a potential unreasonable risk of illness or injury?

Examples: implantable cardiac devices, heart valves, devices that keep a patient alive.

2How would you describe the device’s risk?

Low risk: general controls (registration, labeling, QMS) are enough, e.g. many non-invasive, simple devices. Moderate risk: specific performance standards or special controls are needed.

3Is there a legally marketed device with the same intended use and similar technology (a “predicate”)?

Search the Product Classification Database and 510(k) database for devices like yours.

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