Appendix J: H. R. 4872 – from Reckoning of Time
Source: http://housedocs.house.gov/rules/hr4872/111_hr4872_reported.pdf
Union Calendar No. 256
111TH CONGRESS
2D SESSION
H. R. 4872
To provide for reconciliation pursuant to section 202 of the concurrent
resolution on the budget for fiscal year 2010.
IN THE HOUSE OF REPRESENTATIVES
MARCH 17, 2010
Subtitle C—National Medical
Device Registry
SEC. 2521. NATIONAL MEDICAL DEVICE REGISTRY.
(a) REGISTRY.—
with BILLS
1014
(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
‘‘(B) is—
‘‘(i) a class III device; or
‘‘(ii) a class II device that is implantable, life-supporting, or life-sustaining.
‘‘(2) In developing the registry, the Secretary shall, in consultation with the Commissioner of Food and Drugs, the Administrator of the Centers for Medicare & Medicaid Services, the head of the Office of the National Coordinator for Health Information Technology, and the Secretary of Veterans Affairs, determine the best methods for—
‘‘(B) In this paragraph, the term ‘data’ refers to information respecting a device described in paragraph (1),
including 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.
‘‘(4) Not later than 36 months after the date of the enactment of this subsection, the Secretary shall promulgate regulations for establishment and operation of the registry under paragraph (1). Such regulations—
‘‘(A)(i) in the case of devices that are described in paragraph (1) and sold on or after the date of the enactment of this subsection, shall require manufacturers of such devices to submit information to the registry, including, for each such device, the type, model, and serial number or, if required under subsection (f), other unique device identifier; and
‘‘(ii) in the case of devices that are described in paragraph (1) and sold before such date, may require manufacturers of such devices to submit such information to the registry, if deemed necessary by the Secretary to protect the public health;
(3) CONFORMING AMENDMENT.—Section 303(f)(1)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(1)(B)(ii)) is amended by striking ‘‘519(g)’’ and inserting ‘‘519(h)’’.
(b) ELECTRONIC EXCHANGE AND USE IN CERTIFIED ELECTRONIC HEALTH RECORDS OF UNIQUE DEVICE IDENTIFIERS.—
(1) RECOMMENDATIONS.—The HIT Policy Committee established under section 3002 of the Public Health Service Act (42 U.S.C. 300Jj–12) shall recommend to the head of the Office of the National Coordinator for Health Information Technology standards, implementation specifications, and certification criteria for the electronic exchange and use in certified electronic health records of a unique device identifier for each device described in section 519(g)(1) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).
(2) STANDARDS, IMPLEMENTATION CRITERIA, AND CERTIFICATION CRITERIA.—The Secretary of the Health Human Services, acting through the head of the Office of the National Coordinator for Health Information Technology, shall adopt standards, implementation specifications, and certification criteria for the electronic exchange and use in certified electronic health records of a unique device identifier for each device described in paragraph (1), if such an identifier is required by section 519(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)) for the device.