Class III - Premarket Approval
Class III is the most stringent regulatory category for devices. Class III devices are those for which insufficient information exists to assure safety and effectiveness solely through general or special controls.
Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.
Premarket approval is the required process of scientific review to ensure the safety and effectiveness of Class III devices. Not all Class III devices require an approved premarket approval application to be marketed. Class III devices which are equivalent to devices legally marketed before May 28, 1976 may be marketed through the premarket notification [510(k)] process until FDA has published a requirement for manufacturers of that generic type of device to submit premarket approval data.
Class III devices which require an approved premarket approval application to be marketed are those:
regulated as new drugs prior to May 28, 1976, also called transitional devices.
devices found not substantially equivalent to devices marketed prior to May 28, 1976.
Class III preamendment devices which, by regulation in 21 CFR, require a premarket approval application.
Examples of Class III devices which require a premarket approval include replacement heart valves, silicone gel-filled breast implants, and implanted cerebella stimulators.
Class III devices which can be marketed with a premarket notification 510(k) are those:
postamendment (i.e., introduced to the U.S. market after May 28, 1976) Class III devices which are substantially equivalent to preamendment (i.e., introduced to the U.S. market before May 28, 1976) Class III devices and for which the regulation calling for the premarket approval application has not been published in 21 CFR.
Examples of Class III devices which currently require a premarket notification include implantable pacemaker pulse generators and endosseous implants.