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FDA classification lookup

Describe your device in a few words, or type its three-letter product code. The answer comes straight from FDA's product classification database: the device class, the regulation, the review panel and the usual premarket pathway. No AI, and nothing you type is saved.

Device description or product code

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How to read the answer

• Class is FDA's risk class for that device type: I is lowest, III highest.
• Regulation is the 21 CFR section that defines the device type and any special controls.
• Typical pathway is the route most devices of that type take. Yours can differ: a new intended use or technology can change it.

This is FDA's published classification, not a determination for your device. If the right product code isn't clear, FDA answers that formally through a 513(g) request for information; a qualified regulatory professional can also help. Fees and timelines are not covered here.

Want to keep going? In Regulatory Copilot a device profile carries its classification into pathway strategy, predicate search and the submission. Join the founding cohort for an account.