United States Government Printing Office printer prt distributor dst United States Congress House of Representatives Office of the Law Revision Counsel author aut Government Organization text government publication eng USCODE Bills and Statutes 2006_uscode_suppl_4 legislative 2011-09-06 Sec. 360e D09002ee180df8153-USCODE-2010-title21-chap9-subchapV-partA-sec360e.htm D09002ee180df8154-USCODE-2010-title21-chap9-subchapV-partA-sec360e.pdf http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partA-sec360e 21USC360e http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partA-sec360e/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapV-partA-sec360e.pdf http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partA-sec360e.htm 21 U.S.C. 360e 21 USC 360e 21 U.S.C. 360e 21 USC 360e; FOOD AND DRUGS; Premarket approval 206 LEAF USCODE-2010-title21-chap9-subchapV-partA-sec360e Sec. 360e section standard June 25, 1938, ch. 675, §515, as added Pub. L. 94-295, §2, May 28, 1976, 90 Stat. 552; amended Pub. L. 101-629, §§4(b)(1), 9(a), 18(c), Nov. 28, 1990, 104 Stat. 4515, 4521, 4528; Pub. L. 103-80, §3(t), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105-115, title II, §§201(b), 202, 205(c), 209(b), 216(b), Nov. 21, 1997, 111 Stat. 2334, 2338, 2341, 2349; Pub. L. 107-250, title II, §§209, 210, title III, §302(c), Oct. 26, 2002, 116 Stat. 1613, 1614, 1618; Pub. L. 108-214, §2(d)(1), Apr. 1, 2004, 118 Stat. 576; Pub. L. 110-85, title VIII, §801(b)(3)(D), Sept. 27, 2007, 121 Stat. 921. amendments <b>2007</b>-Subsec. (c)(1)(G), (H). Pub. L. 110-85 added subpar. (G) and redesignated former subpar. (G) as (H).<b>2004</b>-Subsec. (c)(3). Pub. L. 108-214, §2(d)(1)(B), amended directory language of Pub. L. 107-250, §210. See 2002 Amendment note below.Pub. L. 108-214, §2(d)(1)(A)(i), redesignated par. (3) relating to acceptance and review of any portion of the application prior to submission as (4).Subsec. (c)(4). Pub. L. 108-214, §2(d)(1)(A), redesignated par. (3) relating to acceptance and review of any portion of the application prior to submission as (4) and substituted “unless a significant issue of safety” for “unless an issue of safety” in subpar. (B).<b>2002</b>-Subsec. (a). Pub. L. 107-250, §302(c)(1), inserted “or, as applicable, an approval under subsection (c)(2) of this section of a report seeking premarket approval” before period in concluding provisions.Subsec. (c)(2). Pub. L. 107-250, §302(c)(2)(B), added par. (2). Former par. (2) redesignated (3).Subsec. (c)(3). Pub. L. 107-250, §302(c)(2)(A), redesignated par. (2) relating to Secretary's referral of application to appropriate panel as (3).Pub. L. 107-250, §210, as amended by Pub. L. 108-214, §2(d)(1)(B), inserted “Where appropriate, the Secretary shall ensure that such panel includes, or consults with, one or more pediatric experts.” at the end of the concluding provisions of par. (3) as redesignated by Pub. L. 107-250, §302(c)(2)(A).Pub. L. 107-250, §209, added par. (3) relating to acceptance and review of any portion of the application prior to submission.<b>1997</b>-Subsec. (d)(1)(A). Pub. L. 105-115, §205(c)(1), inserted at end “In making the determination whether to approve or deny the application, the Secretary shall rely on the conditions of use included in the proposed labeling as the basis for determining whether or not there is a reasonable assurance of safety and effectiveness, if the proposed labeling is neither false nor misleading. In determining whether or not such labeling is false or misleading, the Secretary shall fairly evaluate all material facts pertinent to the proposed labeling.”Subsec. (d)(1)(B)(iii). Pub. L. 105-115, §201(b), added cl. (iii).Subsec. (d)(3), (4). Pub. L. 105-115, §202(1), 209(b), added par. (3) and redesignated former par. (3) as (4).Subsec. (d)(5). Pub. L. 105-115, §202(2), added par. (5).Subsec. (d)(6). Pub. L. 105-115, §205(c)(2), added par. (6).Subsec. (f)(2). Pub. L. 105-115, §216(b), substituted “the Secretary-” and subpars. (A) and (B) for “he shall refer the proposed protocol to the appropriate panel under section 360c of this title for its recommendation respecting approval of the protocol.”<b>1993</b>-Subsec. (c)(2)(A). Pub. L. 103-80 struck out “refer such application” after “own initiative”.<b>1990</b>-Subsec. (c)(2). Pub. L. 101-629, §18(c), substituted “the Secretary-” for “the Secretary shall” and added subpars. (A) and (B).Subsec. (e). Pub. L. 101-629, §9(a)(2), inserted “and temporary suspension” after “Withdrawal” in heading.Subsec. (e)(3). Pub. L. 101-629, §9(a)(1), added par. (3).Subsec. (i). Pub. L. 101-629, §4(b)(1), added subsec. (i). effectiveDate amendments Amendment by Pub. L. 105-115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105-115, set out as a note under section 321 of this title. false false false Part A Drugs and Devices Volume 86 Page 776 86 Stat. 776 Volume 90 Page 552 90 Stat. 552 Volume 104 Page 4515 104 Stat. 4515 Volume 107 Page 778 107 Stat. 778 Volume 111 Page 2334 111 Stat. 2334 Volume 116 Page 1613 116 Stat. 1613 Volume 116 Page 1612 116 Stat. 1612 Volume 118 Page 576 118 Stat. 576 Volume 121 Page 921 121 Stat. 921 Public Law 92-463 Public Law 94-295 Public Law 101-509 Public Law 101-629 Public Law 101-629 Public Law 103-80 Public Law 103-80 Public Law 105-115 Public Law 105-115 Public Law 107-250 Public Law 107-250 Public Law 108-214 Public Law 108-214 Public Law 110-85 Public Law 110-85 U.S. Government Printing Office 2010-12-31 monographic 2010 annual deposited born digital 711 p. Y 1.2/5: http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21 P0b002ee180df746e 000645501 21USC DGPO 2011-09-06 2011-09-06 USCODE-2010-title21 machine generated eng fdlp USCODE USCODE-2010-title21 21 true 4 2006 false false 2011-01-07 false false USCODE-title21 Title 21 http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21.htm http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21.pdf U.S.C. Title 21, 2010