We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » FDA Exempts 1,003 Class II Devices From 510(k) Regs — But Not GMPs
FDA Exempts 1,003 Class II Devices From 510(k) Regs — But Not GMPs
The FDA finalized its list of 1,003 class II medical devices low-risk enough to be exempt from 510(k) requirements, but stressed that all devices, exempt or otherwise, are subject to current device GMPs, packaging and labeling rules, and regulations on intended use.