FAQs
Q: What are the three types of medical device classes per the FDA?
A: Class I devices are minimum risk potential. They are regulated and controlled to the bare minimum possible extent. Some examples of Class I devices are elastic bandages, examination gloves, stethoscopes, and battery-powered ophthalmic electrolysis units.
Class I device manufacturers must:
Register their manufacturing facilities to ISO 13485 standards
Providing a list of marketed devices regularly to US Food and Drug Administration (or FDA)
Comply with Good Manufacturing Practices (GMP)
Maintaining records of any device malfunctions and resulting injuries caused by the device
Reporting any device removal or corrections
Submit a premarket notification to the FDA before marketing a product, unless the company has exemptions
Class II requires special controls. In addition to submitting a premarket notification, Class II devices must comply with the established performance standards to ensure safety and efficacy. Some examples of Class II devices are powered wheelchairs, infusion pumps, blood pressure monitors, and electrocardiographs. Most of the regulatory requirements are related to the following:
Construction or composition of the device
Device testing
Labeling requirements to ensure proper installation, use, and maintenance
Post-market surveillance
Class III require Premarket approval (PMAs). These are medical devices that are life-sustaining, prevent impairment of health, present an unreasonable risk of injury or illness, and where general controls and performance standards are insufficient to ensure device safety and efficiency are classified as Class III devices. In addition to complying with the control requirements as applicable to Class I and Class II devices, Class III devices must obtain premarket approval before marketing the product. Some devices that establish substantial equivalence to pre-1976 legally marketed devices are not required to obtain premarket approval and can be marketed through the premarket notification process until the FDA publishes a PMA requirement for such devices. Some examples of Class III devices are implantable cardiac pacemakers, silicone gel-filled breast implants, and replacement heart valves.
