United States. Congress

“ 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— `` (i) a class III device; or `` (ii) a class II device that is implantable, life-supporting, or life-sustaining. ”

“ To facilitate analyses of postmarket safety and patient outcomes for devices described in paragraph (1) , the Secretary shall, in collaboration with public, academic, and private entities, develop methods to— `` (i) obtain access to disparate sources of patient safety and outcomes data, including— `` (I) Federal health-related electronic data (such as data from the Medicare program under title XVIII of the Social Security Act or from the health systems of the Department of Veterans Affairs) ”