Health care professional (HCP)

Who the software is for matters in FDA's clinical decision support criteria. Software meant for health care professionals who can review the basis of its recommendations may fall outside the device definition, while similar software for patients or caregivers stays a device.

an individual who is licensed, registered, or certified by a State, territory, or other governing body, to administer health care, including but not limited to, nurse practitioner, registered nurse, licensed practical nurse, clinical social worker, dentist, occupational therapist, pharmacist, physical therapist, physician, physician assistant, psychologist, respiratory therapist, speech-language pathologist, technologist, or any other practitioner or allied health professional.

FDA guidance: Clinical Decision Support Software (January 2026), Footnote 1 (the FDA uses the term HCP to mean ...)