121 STAT. 854
PUBLIC LAW 110–85—SEPT. 27, 2007
SEC. 225. REPORT BY GOVERNMENT ACCOUNTABILITY OFFICE.
(a) IN GENERAL.—The Comptroller General of the United States shall conduct a study on the appropriate use of the process under section 510(k) of the Federal Food, Drug, and Cosmetic Act as part of the device classification process to determine whether a new device is as safe and effective as a classified device. (b) CONSIDERATION.—In determining the effectiveness of the premarket notification and classification authority under section 510(k) and subsections (f) and (i) of section 513 of the Federal Food, Drug, and Cosmetic Act, the study under subsection (a) shall consider the Secretary of Health and Human Services’s evaluation of the respective intended uses and technologies of such devices, including the effectiveness of such Secretary’s comparative assessment of technological characteristics such as device materials, principles of operations, and power sources. (c) REPORT.—Not later than 1 year after the date of the enactment of this Act, the Comptroller General shall complete the study under subsection (a) and submit to the Congress a report on the results of such study.
Study.
SEC. 226. UNIQUE DEVICE IDENTIFICATION SYSTEM.
(a) IN GENERAL.—Section 519 (21 U.S.C. 360i) is amended— (1) by redesignating subsection (f) as subsection (g); and (2) by inserting after subsection (e) the following: ‘‘Unique Device Identification System ‘‘(f) The Secretary shall promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device through distribution and use, and may include information on the lot or serial number.’’. (b) CONFORMING AMENDMENT.—Section 303 (21 U.S.C. 333) is amended— (1) by redesignating the subsection that follows subsection (e) as subsection (f); and (2) in paragraph (1)(B)(ii) of subsection (f), as so redesignated, by striking ‘‘519(f)’’ and inserting ‘‘519(g)’’.
Regulations.
SEC. 227. FREQUENCY OF REPORTING FOR CERTAIN DEVICES.
dkrause on GSDDPC44 with PUBLAW
Federal Register, publication.
VerDate Aug 31 2005
13:52 Jan 23, 2009
Subparagraph (B) of section 519(a)(1) (21 U.S.C. 360i(a)(1)) is amended by striking ‘‘were to recur;’’ and inserting the following: ‘‘were to recur, which report under this subparagraph— ‘‘(i) shall be submitted in accordance with part 803 of title 21, Code of Federal Regulations (or successor regulations), unless the Secretary grants an exemption or variance from, or an alternative to, a requirement under such regulations pursuant to section 803.19 of such part, if the device involved is— ‘‘(I) a class III device; ‘‘(II) a class II device that is permanently implantable, is life supporting, or is life sustaining; or ‘‘(III) a type of device which the Secretary has, by notice published in the Federal Register or letter to the person who is the manufacturer
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