Law360 (February 5, 2021, 6:11 PM EST) — Medical devices and manufacturers of these devices are regulated by the Center for Devices and Radiological Health at the U.S. Food and Drug Administration. These devices receive one of three classifications: Class I, II or III.
Class I devices “generally pose the lowest risk to the patient and/or user [while] Class III devices pose the highest risk.”[1] The vast majority of devices are approved under premarket approval or cleared under Premarket Notification 510(k),[2] often referred to simply as 510(k).[3] However, the FDA does exempt certain Class I and II devices from 510(k) requirements.[4]
Premarket approval are required for “high risk devices…
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