Compliance Policy GuideCompliance Policy Guidance for FDA StaffRevocation/DeletionSec. 300.700 Direct Reference Authority for Class III Medical Devices Without a Premarket Notification (510(k)) or an Approved Premarket Approval Application (PMA) (CPG 7124.30)REVOKED effective October 07, 2002 per Federal Register dated September 05, 2002 (67 FR 56850) Issued: 2/26/91 Page created 10/15/2002 (tc) |