Glossary
510(k) clearance
The FDA pathway that lets a device, including AI software, reach market by showing it is substantially equivalent to an already-authorised predicate device.
Most of the more than a thousand AI-enabled medical devices FDA has authorised went through 510(k) rather than the more demanding de novo or premarket approval routes. The pathway works when the intended use is narrow and a comparable predicate exists; it fits poorly with models that update frequently or systems with broad clinical roles, which is what predetermined change-control plans and proposals such as the PATIENT AI Act try to address.
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