class III device

A highly-regulated ‘high risk’ medical device—e.g., pacemakers and heart valves—approved by the FDA for use in humans

class III device

Regulatory affairs A highly regulated 'high risk' medical device–eg, life-support or life-sustaining devices–eg, pacemakers and heart valves, approved by the FDA for use in humans; CIIIDs are also defined as those which pose a potentially unreasonable risk of illness or injury. See Medical device.
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Through the premarket approval process, the manufacturer of a Class III device must demonstrate that the device they intend to market is safe and effective for its intended use.
CES has been in flux with the FDA since 1978, when it initially was labeled a class III device and until the agency could determine its proper classification.
Generally, before a Class III device may be marketed, it must
Whereas a Class 1 device must only be listed with the FDA, and a Class II device must be cleared by the FDA, a Class III device must be approved by the FDA.
Although Congress envisioned that class III devices would be approved through the more stringent PMA process, and the Safe Medical Devices Act of 1990 required that FDA either reclassify or establish a schedule for requiring PMAs for class III device types, this process remains incomplete.
The catheter is a Class III device that received FDA premarket approval.
Before a manufacturer can market a Class III device, it must obtain approval from the FDA.
The FDA thus ruled the cap card a Class III device, whose use is potentially as life-threatening or life-sustaining as an artificial lung or a dialysis machine.
Thus, Congress has mandated that, where the preamendment device is a Class III device, FDA give direct consideration to questions regarding safety and effectiveness.
Clinical trials are required for clearance of devices that are regulated as class III devices, and the ACOG - AUGS statement notes that the FDA is considering whether to reclassify mesh products intended for vaginal repair of POP to a class III device.