Medical devices; revocation of cardiac pacemaker registry. Food and Drug Administration, HHS. Final rule.
The Food and Drug Administration (FDA) is issuing a final rule to revoke a regulation requiring a cardiac pacemaker registry. The registry, which was mandated by the Deficit Reduction Act of 1984, requires any physician and any provider of services who requests or receives Medicare payment for an implantation, removal, or replacement of permanent cardiac pacemaker devices and pacemaker leads to submit certain information to the registry. The information is used by FDA to track the performance of permanent cardiac pacemakers and pacemaker leads and by the Health Care Finance Administration (HCFA) to administer its Medicare payment program for these devices. This action is being taken to implement an act to Repeal An Unnecessary Medical Device Reporting Requirement passed by Congress in 1996 to remove the cardiac pacemaker registry to eliminate duplicative and unnecessary reporting.
D014487:Centers for Medicare and Medicaid Services, U.S.; D017147:Defibrillators, Implantable / Q000592:standards*; D006801:Humans; D006278:Medicare; D012042:Registries / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration