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.
A key requirement of the policy is that the facilities must obtain a device manufacturing permit, which will raise the bar for the domestic industry. Read More
Conventional Foley catheters and cutaneous electrodes are the first two types of devices to get their own final guidances under the FDA’s new safety and performance-based pathway for 510(k) marketing clearance. Read More