H.R 3962 BILL (2009)

http://housedocs.house.gov/rules/health/111_ahcaa.pdf

(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 sub- section (h); and

(B) by inserting after subsection (f) the following:

‘‘National Medical Device Registry
‘‘(g)(1)(A) 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 covered device.
‘‘(B) In this subsection, the term ‘covered device’—

‘‘(i) shall include each class III device; and

‘‘(ii) may include, as the Secretary determines appropriate and specifies in regulation, a class II de- vice that is life-supporting or life-sustaining.
‘‘(C) Notwithstanding subparagraph (B)(i), the Sec-

retary may by order exempt a class III device from the provisions of this subsection if the Secretary concludes that inclusion of information on the device in the registry will not provide useful information on safety or effective- ness.

‘‘(2) In developing the registry, the Secretary shall, in consultation with the Commissioner of Food and Drugs 

© Ruth Zoe Andreas, all rights reserved