Reblogged from http://boudicabpi.wordpress.com/2012/07/26/14425/
H.R. 3200 section 2521, Pg. 1001, paragraph 1.
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— ‘‘is or has been used in or on a patient; ‘‘and is— ‘‘a class III device; or ‘‘a class II device that is implantable, life-supporting, or life-sustaining.”
What exactly is a class II device that is implantable? As you saw earlier, it is the device approved by the FDA in 2004.
Federal Food, Drug, and Cosmetic Act:
A class II implantable device is an “implantable radio frequency transponder system for patient identification and health information.” The purpose of a class II device is to collect data in medical patients such as “claims data, patient survey data, standardized analytic files that allow for the pooling and analysis of data from disparate data environments, electronic health records, and any other data deemed appropriate by the Secretary.”