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.
San Diego devicemaker Dr. Joel Kaplan, Inc., received an FDA warning letter for off-label claims about its penis pumps, including advertising the devices online to fix penile curvature. 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