2s.io

FDA medical device classification — the regulatory class and controls for a device type. Search by device name or FDA product code and get back the device class (I/II/III, mapping to regulatory risk and controls), CFR regulation number, medical specialty/review panel, the official definition, and flags for life-sustaining/supporting, implant, GMP-exempt, and third-party-review eligibility. Free, public-domain US government data. The authoritative answer to "what FDA class is this device and what

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