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.
Devicemakers will be able to submit traditional 510(k)s electronically to two branches in the U.S. Food and Drug Administration’s Center for Devices and Radiological Health, under an experimental program announced May 1. Read More
The U.S. Food and Drug Administration is proposing a new, voluntary program to speed the approval of devices that address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions. Read More
Devicemakers often misuse voluntary consensus standards in premarket submissions, the FDA says, by using versions of standards that the agency doesn’t recognize or using consensus standards that don’t apply to their specific device or testing methods. Read More