Final FDA Rule Sets Application Requirements for Manufacturers of Pacemakers
| Posted: 22 June 2012
By Alexander Gaffney
Manufacturers of implantable pacemaker pulse generators and the devices that program them are receiving a final rule from the US Food and Drug Administration (FDA) today informing them of new application filing requirements coming into effect in September 2012.
In two separate 22 June Federal Register postings, FDA said manufacturers of pacemaker devices and pacemaker programmers will now be required to file a premarket approval application (PMA) or a complete product development protocol (PDP) to the agency.
Previously, devices cleared by the agency before the passage of the 1976 Medical Device Amendments and devices claiming 510(k) substantial equivalence to those devices could avoid the PMA and PDP processes, FDA wrote. Under the new rules, FDA will require both types of devices to be submitted to the agency via a PMA or PDP regardless of when the device came into commercial distribution. For marketers of devices with previously-approved 510(k) or exempt medical devices, this will require a PMA to be submitted to FDA, the agency said.
FDA - Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer
FDA - Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator
Mass Device - FDA formalizes PMA requirement for all implantable pacemakers, programmers