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 » Guidance: Adding Antimicrobials To Devices Requires New 510(k)s
Guidance: Adding Antimicrobials To Devices Requires New 510(k)s
July 27, 2007
Adding an antimicrobial agent to a marketed medical device generally represents a “significant modification” that requires a new 510(k) submission, the FDA said in a recent draft guidance.