Intended Use
Also called: indications for use
The specific clinical purpose, population, and setting a device is authorized for, which defines the boundary of its clearance.
Intended use is the statement of what a device is for: which condition, which patients, which clinical setting, and in what role. It determines the regulatory pathway, the required evidence, and the legal scope of the authorization.
A triage indication and a diagnostic indication for identical software are different intended uses requiring different evidence.
Where This Gets Misread
Using a device outside its intended use is off-label, and it is easy to do without noticing because the software will happily produce output. A device validated in adults will return a result on a paediatric study. The result is not covered by anything, and the clinician owns it entirely.