Medical devices include pacemakers and dental drills
- April 29, 2019
Medical devices can be as commonplace as blood pressure monitors or as leading edge as the artificial pancreas easing the lives of people with diabetes.
The FDA defines a medical device as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reactant or components which are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or animals or intended to affect the structure or any function of the body.
A subsector of the bioscience industry, the category includes businesses that develop and manufacture surgical and medical instruments and supplies, laboratory equipment, electromedical apparatus, including MRI and ultrasound equipment, dental equipment and supplies.
- Electromedical and electrotherapeutic devices — pacemakers, diagnostic-imaging equipment and ultrasonic-scanning devices.
- Irradiation apparatuses — X-ray machines and CT scanners.
- Surgical and medical supplies — syringes, needles and equipment for optical diagnoses, blood transfusion and anesthesia.
- Surgical appliances and supplies — artificial joints and limbs, stents and wheelchairs.
- Dental equipment and supplies — drills, amalgams and dental chairs.
- Analytical laboratory instruments — bioimaging and genomic sequencing equipment.
The Food and Drug Administration assigns devices to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the product. A 2002 law authorized the FDA to charge businesses a premarket review fee as a way to ensure timely evaluation of devices.