By Nick Otto
The FDA is proposing to reclassify both external pacemaker pulse generator (EPPG) devices and pacing system analyzers (PSAs) as class II devices with special controls.
EPPGs are devices that act as temporary alternatives to a pacemaker. An EPPG “has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart,” the agency writes in a recent Federal Register notice. “This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following events such as cardiac surgery or a myocardial infarction.”
A PSA combines the functionality of a pacemaker electrode function tester and an EPPG, and can temporarily take over pacing functions while simultaneously testing one or more implanted pacing leads, according to the notice.
The agency says that recent data show that the EPPG, together with the recommended special controls, provides reasonable assurance of its safety and effectiveness. In addition, new separate classifications for PSAs will create a special classification, “including single, dual, and triple chamber PSA devices that will be reclassified from class III to class II,” according to the notice.
The agency says supporting evidence to reclassify EPPG devices includes a low reporting of serious adverse events to the FDA's Manufacturer and User Facility Device Experience database, as well as a low rate of postmarket recalls. Similar reasoning was used in the FDA’s decision on downgrading PSA classes as well.
However, makers of EPPG devices have some new requirements to justify the device-class downgrade, including:
- Electromagnetic compatibility testing and analysis must be validated in a hospital setting.
- Electrical bench testing must demonstrate device safety during intended use. This must include testing with the specific power source such as battery power, AC mains connections, or both.
- Appropriate software verification, validation, and hazard analysis must be performed.
- The devices must adhere to several labeling requirements.
Similar requirements such as hospital environment testing, electrical bench testing, and software verifications must be performed for PSA devices.
Device makers have until Dec. 15 to comment on the proposal.