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 » Court: FDA Can Revoke 510(k) If Action Timely, Not Arbitrary
Court: FDA Can Revoke 510(k) If Action Timely, Not Arbitrary
May 3, 2013
The FDA acted appropriately in ordering a collagen implant off the market until a PMA was obtained, the D.C. district court says, rejecting the manufacturer’s claim that the agency’s decision was arbitrary and capricious.