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 » Industry, Patient Advocates Spar Over Need for 510(k)s for Modifications
Industry, Patient Advocates Spar Over Need for 510(k)s for Modifications
June 14, 2013
Industry’s case against significant reforms to the FDA’s policy on when devicemakers must submit a new 510(k), made during a Thursday public meeting, drew pushback from consumer groups that argued current controls don’t ensure patient safety.