FDA Proposes Premarket Notification Exemptions for Class II Medical Devices
February 06, 2026
February 06, 2026
WASHINGTON, Feb. 6 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued a notice identifying a list of class II medical devices that may soon be exempt from premarket notification requirements. This proposal aims to decrease regulatory burdens and costs for the medical device industry.
Under current regulations, manufacturers of class II devices must typically submit a 510(k) premarket notification to demonstrate that a device is "subs . . .
Under current regulations, manufacturers of class II devices must typically submit a 510(k) premarket notification to demonstrate that a device is "subs . . .