Page:United States Statutes at Large Volume 121.djvu/886

This page needs to be proofread.
[121 STAT. 865]
[121 STAT. 865]
PUBLIC LAW 110-000—MMMM. DD, 2007

PUBLIC LAW 110–85—SEPT. 27, 2007

121 STAT. 865

(b) PEDIATRIC ADVISORY COMMITTEE.—Section 14 of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended— (1) in subsection (a), by inserting ‘‘(including drugs and biological products) and medical devices’’ after ‘‘therapeutics’’; and (2) in subsection (b)— (A) in paragraph (1), by inserting ‘‘(including drugs and biological products) and medical devices’’ after ‘‘therapeutics’’; and (B) in paragraph (2)— (i) in subparagraph (A), by striking ‘‘and 505B’’ and inserting ‘‘505B, 510(k), 515, and 520(m)’’; (ii) by striking subparagraph (B) and inserting the following: ‘‘(B) identification of research priorities related to therapeutics (including drugs and biological products) and medical devices for pediatric populations and the need for additional diagnostics and treatments for specific pediatric diseases or conditions;’’; and (iii) in subparagraph (C), by inserting ‘‘(including drugs and biological products) and medical devices’’ after ‘‘therapeutics’’. SEC. 307. POSTMARKET SURVEILLANCE.

Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l) is amended— (1) by amending the section heading and designation to read as follows: ‘‘SEC. 522. POSTMARKET SURVEILLANCE.’’;

dkrause on GSDDPC44 with PUBLAW

(2) by striking subsection (a) and inserting the following: ‘‘(a) POSTMARKET SURVEILLANCE.— ‘‘(1) IN GENERAL.— ‘‘(A) CONDUCT.—The Secretary may by order require a manufacturer to conduct postmarket surveillance for any device of the manufacturer that is a class II or class III device— ‘‘(i) the failure of which would be reasonably likely to have serious adverse health consequences; ‘‘(ii) that is expected to have significant use in pediatric populations; or ‘‘(iii) that is intended to be— ‘‘(I) implanted in the human body for more than 1 year; or ‘‘(II) a life-sustaining or life-supporting device used outside a device user facility. ‘‘(B) CONDITION.—The Secretary may order a postmarket surveillance under subparagraph (A) as a condition to approval or clearance of a device described in subparagraph (A)(ii). ‘‘(2) RULE OF CONSTRUCTION.—The provisions of paragraph (1) shall have no effect on authorities otherwise provided under the Act or regulations issued under this Act.’’; and (3) in subsection (b)— (A) by striking ‘‘(b) SURVEILLANCE APPROVAL.—Each’’ and inserting the following: ‘‘(b) SURVEILLANCE APPROVAL.—

VerDate Aug 31 2005

13:52 Jan 23, 2009

Jkt 059194

PO 00001

Frm 00863

Fmt 6580

Sfmt 6581



PsN: 59194PT1