Definition Of A Medical Device As Outlined Under Section 2 Of Act 737

 

Section 2 defines a “medical device” as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for the purpose of:

  1. diagnosis, prevention, monitoring, treatment, or alleviation of disease;
  2. diagnosis, monitoring, treatment, alleviation of, or compensation for an injury;
  3. investigation, replacement, modification, or support of the anatomy or a physiological process;
  4. supporting or sustaining life;
  5. control of conception;
  6. disinfection of a medical device; or
  7. providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body