MDC: Not HPO. Death? (46)

Is the device intended for one or more of the following?

1. Diagnose or screen for a disease or condition that:
   1. would NOT lead to the death of a person, or a severe deterioration in the state of a person’s health without urgent treatment, or
   2. is NOT a serious disease or serious condition,
   3. does NOT pose a risk to public health
2. Monitor the state or progression of a disease, condition or parameter that does not indicate whether:
   1. the person or another person may be in danger (but not immediate danger), or
   2. there may be a moderate risk to public health
3. Specify or recommend a treatment or intervention, where the treatment or intervention, or its absence:
   1. would not cause harm to a person, or
   2. does NOT pose a risk to public health
4. Provide information as therapy to a person that may cause harm to the person (not serious harm, death, or a severe deterioration in the state of the person’s health)
5. Administer or exchange energy to or from a patient (where the energy is non-hazardous)
6. Supply energy that will be absorbed by a patient’s body (other than a device that is intended only to illuminate the patient’s body in the visible spectrum)
7. Image in vivo distribution of radiopharmaceuticals in a patient
8. Used to allow direct diagnosis or monitoring of vital physiological processes of a patient (other than those that could result in immediate danger to the patient)
9. Used to administer or remove medicine, body liquids or other substances (that are non-hazardous) to or from a patient.