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. 379i D09002ee180df8153-USCODE-2010-title21-chap9-subchapVII-partC-subpart3-sec379i.htm D09002ee180df8154-USCODE-2010-title21-chap9-subchapVII-partC-subpart3-sec379i.pdf http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapVII-partC-subpart3-sec379i 21USC379i http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapVII-partC-subpart3-sec379i/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapVII-partC-subpart3-sec379i.pdf http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapVII-partC-subpart3-sec379i.htm 21 U.S.C. 379i 21 USC 379i 21 U.S.C. 379i 21 USC 379i; FOOD AND DRUGS; Definitions 285 LEAF USCODE-2010-title21-chap9-subchapVII-partC-subpart3-sec379i Sec. 379i section standard June 25, 1938, ch. 675, §737, as added Pub. L. 107-250, title I, §102(a), Oct. 26, 2002, 116 Stat. 1589; amended Pub. L. 108-214, §2(a)(1), (d)(3)(A), Apr. 1, 2004, 118 Stat. 572, 577; Pub. L. 110-85, title II, §211, Sept. 27, 2007, 121 Stat. 843. futureAmend For termination of amendment by section 217 of Pub. L. 110-85, see Effective and Termination Dates of 2007 Amendment note below.For termination of section by section 107 of Pub. L. 107-250, see Effective and Termination Dates note set out below. amendments <b>2007</b>-Pub. L. 110-85, §§211(1), 217, temporarily substituted “For purposes of this subpart” for “For purposes of this part” in introductory provisions. See Effective and Termination Dates of 2007 Amendment note below.Pars. (5) to (9). Pub. L. 110-85, §§211(2), (3), 217, temporarily added pars. (5) to (7) and redesignated former pars. (5) and (6) as (8) and (9), respectively. Former pars. (7) and (8) redesignated (10) and (12), respectively. See Effective and Termination Dates of 2007 Amendment note below.Par. (10). Pub. L. 110-85, §§211(2), (4), 217, temporarily redesignated par. (7) as (10) and substituted “October of the preceding fiscal year” for “April of the preceding fiscal year” and “October 2001” for “April 2002”. See Effective and Termination Dates of 2007 Amendment note below.Par. (11). Pub. L. 110-85, §§211(5), 217, temporarily added par. (11). See Effective and Termination Dates of 2007 Amendment note below.Par. (12). Pub. L. 110-85, §§211(2), 217, temporarily redesignated par. (8) as (12). See Effective and Termination Dates of 2007 Amendment note below.Par. (13). Pub. L. 110-85, §§211(6), 217, temporarily added par. (13). See Effective and Termination Dates of 2007 Amendment note below.<b>2004</b>-Pub. L. 108-214, §2(d)(3)(A), made technical correction to directory language of Pub. L. 107-250, §102(a), which enacted this section.Par. (4)(B). Pub. L. 108-214, §2(a)(1)(A), substituted “and for which substantial clinical data are necessary to provide a reasonable assurance of safety and effectiveness” for “and for which clinical data are generally necessary to provide a reasonable assurance of safety and effectiveness”.Par. (4)(D). Pub. L. 108-214, §2(a)(1)(B), struck out “manufacturing,” after “software,”.Par. (5)(J). Pub. L. 108-214, §2(a)(1)(C), substituted “a premarket application or premarket report under section 360e of this title or a premarket application under section 262 of title 42.” for “a premarket application under section 360e of this title or section 262 of title 42.”Par. (8). Pub. L. 108-214, §2(a)(1)(D), substituted “The term ‘affiliate’ means a business entity that has a relationship with a second business entity (whether domestic or international)” for “The term ‘affiliate’ means a business entity that has a relationship with a second business entity”. savingsProvision Pub. L. 110-85, title II, §214, Sept. 27, 2007, 121 Stat. 852, provided that: “Notwithstanding section 107 of the Medical Device User Fee and Modernization Act of 2002 (Public Law 107-250) [set out as an Effective and Termination Dates note above], and notwithstanding the amendments made by this subtitle [subtitle A (§§211-217) of title II of Pub. L. 110-85, enacting section 379j-1 of this title and amending this section and section 379j of this title], part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this subtitle [Sept. 27, 2007], shall continue to be in effect with respect to premarket applications, premarket reports, premarket notification submissions, and supplements (as defined in such part as of such day) that on or after October 1, 2002, but before October 1, 2007, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2008.” false false false

Title 21 Section 379i Title 21 Section 379iet seq. Title 21 Section 379j-1 Title 21 Section 379j 21 U.S.C. 379i 21 U.S.C. 379iet seq. 21 U.S.C. 379j-1 21 U.S.C. 379j Volume 116 Page 1589 116 Stat. 1589 Volume 116 Page 1589 Volume 116 Page 1600 Volume 116 Page 1601 Volume 116 Page 1602 116 Stat. 1589 116 Stat. 1600 116 Stat. 1601 116 Stat. 1602 Volume 118 Page 572 118 Stat. 572 Volume 119 Page 441 119 Stat. 441 Volume 121 Page 843 121 Stat. 843 Volume 121 Page 842 Volume 121 Page 852 121 Stat. 842 121 Stat. 852 Public Law 107-250 Public Law 107-250 Public Law 108-214 Public Law 108-214 Public Law 109-43 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