Patient

FDA separates patients from subjects so that statements on benefit and risk are clear about whether they come from clinical practice or from a clinical investigation.

living being (person) undergoing a medical, surgical or dental PROCEDURE Note 1 to entry: A PATIENT can be a USER. [SOURCE: IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, 3.76, modified – The phrase ‘or animal’ has been deleted from the definition and "USER" has been substituted for "operator" in the note to entry.]

IEC 62366-1:2015+AMD1:2020, clause 3.10

In general, for the purposes of this guidance, the use of the term “patient” refers to an individual who is under medical care or treatment and is not a subject, and the use of the term “subject” refers to an individual who participates in a clinical investigation.

FDA guidance: Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (August 2019), Footnote 7