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[SIZE=2]Subtitle C—National Medical

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10 Device Registry

11 SEC. 2521. NATIONAL MEDICAL DEVICE REGISTRY.

12 (a) REGISTRY.—

13 (1) IN GENERAL.—Section 519 of the Federal

14 Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is

15 amended—

16 (A) by redesignating subsection (g) as sub17

section (h); and

18 (B) by inserting after subsection (f) the

19 following:

20 ‘‘National Medical Device Registry

21 ‘‘(g)(1) The Secretary shall establish a national med22

ical device registry (in this subsection referred to as the

23 ‘registry’) to facilitate analysis of postmarket safety and

24 outcomes data on each device that—

25 ‘‘(A) is or has been used in or on a patient; and

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1 ‘‘(B) is—

2 ‘‘(i) a class III device; or

3 ‘‘(ii) a class II device that is implantable,

4 life-supporting, or life-sustaining.

5 ‘‘(2) In developing the registry, the Secretary shall,

6 in consultation with the Commissioner of Food and Drugs,

7 the Administrator of the Centers for Medicare & Medicaid

8 Services, the head of the Office of the National Coordi9

nator for Health Information Technology,


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