A recent publication made in the Federal Register on April 18th, 2016 from the U.S Food and Drug Administration (FDA) has reclassified external pacemaker pulse generators (EPPG) devices and pacing system analyzers (PSAs) as Class II Medical Devices when they are currently Class III. This update also created a separate classification regulation for PSAs which are presently classified within the same jurisdiction as EPPG devices.
An EPPG delivers an electrical pulse that is used to stimulate and pace the heart temporarily until a permanent pacemaker can be implanted. A PSA is another medical device which combines the functionality of a pacemaker electrode function tester in with an EPPG.
In 2013, a panel of medical experts supported the reclassification of EPPG and PSA devices. The results from the Panel were that “EPPG devices be reclassified to Class II with special controls when intended for cardiac rate control or prophylactic arrhythmia prevention”. Since the 2013 Panel meeting, the FDA has not become aware of any new information that would provide a basis for a more recent panel to make a different recommendation. The agency has therefore agreed with the 2013 Panel’s recommendations and following the effective date of this Final Order, firms that are marketing an EPPG or PSA device must comply with the mitigation measures that have been put into place for these medical devices.
Product manufacturers entering the American market must pay close attention to the different regulations in regards to Medical Devices in order to be successful in this growing industry. Focal Point Research has offered services as Medical Device Consultants for over 20 years; and we offer and immense knowledge of their regulations. Contact us if you need assistance bringing your medical devices to market.