Subtitle C-11 Sec. 2521— National Medical Device Registry, and which states its purpose as:
“The Secretary shall establish a national medical device registry (in this subsection referred to as the ‘registry’) to facilitate analysis of postmarket safety and outcomes data on each device that—‘‘(A) is or has been used in or on a patient; and ‘‘(B) is a class III device; or ‘‘(ii) a class II device that is implantable.”
Approved by the FDA, a class II implantable device is an “implantable radiofrequency transponder system for patient identification and health information.