If All the Parts Have Been Replaced, Is It Still the Same Appliance?

The FDA designates a medical device as Class III if it “presents a potential, unreasonable risk of illness or injury.” For such devices, manufacturers are required to submit clinical data to support their claims through a premarket approval (PMA) process. However, if changes to approved Class III devices are considered incremental innovations, they can bypass the PMA requirement of clinical data via a supplement pathway.

These investigators used the FDA database to determine the frequency by which supplement pathways are used for approval of changes to cardiac implantable electronic devices (CIEDs; including implantable cardioverter-defibrillators, pacemakers, and cardiac resynchronization therapy devices) and the characteristics of the appr…