America's Affordable Health Choices Act of 2009 (Introduced in House)
Subtitle C--National Medical Device Registry
SEC. 2521. NATIONAL MEDICAL DEVICE REGISTRY.
(1) IN GENERAL- Section 519 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is amended--
(A) by redesignating subsection (g) as subsection (h); and
(B) by inserting after subsection (f) the following:
`National Medical Device Registry
`(g)(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--
`(A) is or has been used in or on a patient; and
`(i) a class III device; or
`(ii) a class II device that is implantable, life-supporting, or life-sustaining.
[link to thomas.loc.gov