PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 859
(b) CONSUMER TESTING.—In making the determinations under subsection (a), the Secretary shall conduct appropriate consumer testing to determine consumer understanding of label warnings. (c) REPORT.—Not later than 1 year after the date of the enactment of this Act, the Secretary shall submit to the Congress a report that provides the determinations under subsection (a). In addition, the Secretary shall include in the report the measures being implemented by the Secretary to significantly reduce the risks associated with indoor tanning devices.
TITLE III—PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007
Pediatric Medical Device Safety and Improvement Act of 2007.
SEC. 301. SHORT TITLE.
21 USC 301 note.
This title may be cited as the ‘‘Pediatric Medical Device Safety and Improvement Act of 2007’’. SEC. 302. TRACKING PEDIATRIC DEVICE APPROVALS.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 515 the following: ‘‘SEC. 515A. PEDIATRIC USES OF DEVICES.
21 USC 360e–1.
dkrause on GSDDPC44 with PUBLAW
‘‘(a) NEW DEVICES.— ‘‘(1) IN GENERAL.—A person that submits to the Secretary an application under section 520(m), or an application (or supplement to an application) or a product development protocol under section 515, shall include in the application or protocol the information described in paragraph (2). ‘‘(2) REQUIRED INFORMATION.—The application or protocol described in paragraph (1) shall include, with respect to the device for which approval is sought and if readily available— ‘‘(A) a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and ‘‘(B) the number of affected pediatric patients. ‘‘(3) ANNUAL REPORT.—Not later than 18 months after the date of the enactment of this section, and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes— ‘‘(A) the number of devices approved in the year preceding the year in which the report is submitted, for which there is a pediatric subpopulation that suffers from the disease or condition that the device is intended to treat, diagnose, or cure; ‘‘(B) the number of devices approved in the year preceding the year in which the report is submitted, labeled for use in pediatric patients; ‘‘(C) the number of pediatric devices approved in the year preceding the year in which the report is submitted, exempted from a fee pursuant to section 738(a)(2)(B)(v); and
VerDate Aug 31 2005
13:52 Jan 23, 2009