The US Food and Drug Administration may reclassify external pacemaker pulse generators from Class III to Class II, contending that the 510(k) premarket notification process is sufficient to address risks associated with these devices.
External pacemaker pulse generators serve as temporary substitutes for cardiac pacing systems prior to implanting permanent pacemakers in patients as well as for controlling irregular heartbeats. The FDA has issued Class II special controls guidance specifically for devices with product code DTE. The guidance does not cover devices indicated for use in cardiac resynchronization therapy, pacemaker electrode function testers or temporary pacemaker electrodes.
The guidance lists several special controls that, if reclassification of external pacemaker pulse generators goes into effect, would have to be followed by manufacturers as part of their 510(k) review process. These include pre-510(k) risk analysis, through device description and software validation.
Devices should also be evaluated for electrical safety according to FDA-recognized standards such as IEC 60601, as well as for electromagnetic compatibility in terms of both emissions and immunity. Performance testing and labeling instructions are also included.
Importantly, clinical studies will not be required for most new external pacemaker pulse generators if their Class II designation is finalized. FDA reviewers may require clinical study data, however, for devices with new features; new technology; different indications for use; or for questionable results from bench or animal testing.
