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. 360c D09002ee180df8153-USCODE-2010-title21-chap9-subchapV-partA-sec360c.htm D09002ee180df8154-USCODE-2010-title21-chap9-subchapV-partA-sec360c.pdf http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partA-sec360c 21USC360c http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partA-sec360c/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapV-partA-sec360c.pdf http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partA-sec360c.htm 21 U.S.C. 360c 21 USC 360c 21 U.S.C. 360c 21 USC 360c; FOOD AND DRUGS; Classification of devices intended for human use 204 LEAF USCODE-2010-title21-chap9-subchapV-partA-sec360c Sec. 360c section standard June 25, 1938, ch. 675, §513, as added Pub. L. 94-295, §2, May 28, 1976, 90 Stat. 540; amended Pub. L. 101-629, §§4(a), 5(a)-(c)(1), (3), 12(a), 18(a), Nov. 28, 1990, 104 Stat. 4515, 4517, 4518, 4523, 4528; Pub. L. 102-300, §6(e), June 16, 1992, 106 Stat. 240; Pub. L. 103-80, §3(s), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105-115, title II, §§205(a), (b), 206(b), (c), 207, 208, 217, Nov. 21, 1997, 111 Stat. 2336, 2337, 2339, 2340, 2350; Pub. L. 107-250, title II, §208, Oct. 26, 2002, 116 Stat. 1613. Medical Device Amendments of 1976 referencesInText The Federal Advisory Committee Act, referred to in subsec. (b)(1), (8), is Pub. L. 92-463, Oct. 6, 1972, 86 Stat. 770, as amended, which is set out in the Appendix to Title 5, Government Organization and Employees. amendments <b>2002</b>-Subsec. (i)(1)(E)(iv). Pub. L. 107-250 struck out cl. (iv) which read as follows: “This subparagraph has no legal effect after the expiration of the five-year period beginning on November 21, 1997.”<b>1997</b>-Subsec. (a)(3)(A). Pub. L. 105-115, §217, substituted “1 or more clinical investigations” for “clinical investigations”.Subsec. (a)(3)(C), (D). Pub. L. 105-115, §205(a), added subpars. (C) and (D).Subsec. (b)(5) to (8). Pub. L. 105-115, §208, added pars. (5) to (8).Subsec. (f)(1). Pub. L. 105-115, §207(1)(B), substituted “paragraph (2) or (3)” for “paragraph (2)” in closing provisions.Subsec. (f)(1)(B). Pub. L. 105-115, §207(1)(A), substituted “paragraph (3)” for “paragraph (2)”.Subsec. (f)(2) to (4). Pub. L. 105-115, §207(2), (3), added par. (2) and redesignated former pars. (2) and (3) as (3) and (4), respectively.Subsec. (f)(5). Pub. L. 105-115, §206(b), added par. (5).Subsec. (i)(1)(A)(ii). Pub. L. 105-115, §206(c)(1), substituted “appropriate clinical or scientific data” for “clinical data”, inserted “or a person accredited under section 360m of this title” after “Secretary”, and substituted “effectiveness” for “efficacy”.Subsec. (i)(1)(C) to (E). Pub. L. 105-115, §205(b), added subpars. (C) to (E).Subsec. (i)(1)(F). Pub. L. 105-115, §206(c)(2), added subpar. (F).<b>1993</b>-Subsec. (b)(3). Pub. L. 103-80 substituted “5703” for “5703(b)”.<b>1992</b>-Subsec. (f)(3). Pub. L. 102-300 redesignated clauses (i) to (iii) as subpars. (A) to (C), respectively, and substituted “the section 360(k) report” for “the 360(k) report” in closing provisions.<b>1990</b>-Subsec. (a)(1)(A)(ii). Pub. L. 101-629, §5(a)(1), substituted “or to establish special controls” for “or to establish a performance standard”.Subsec. (a)(1)(B). Pub. L. 101-629, §5(a)(2), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: “<cap-smallcap>Class II, Performance Standards</cap-smallcap>.-A device which cannot be classified as a class I device because the controls authorized by or under sections 351, 352, 360, 360f, 360h, 360i, and 360j of this title by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, for which there is sufficient information to establish a performance standard to provide such assurance, and for which it is therefore necessary to establish for the device a performance standard under section 360d of this title to provide reasonable assurance of its safety and effectiveness.”Subsec. (a)(1)(C)(i). Pub. L. 101-629, §5(a)(3), amended cl. (i) generally. Prior to amendment, cl. (i) read as follows: “it (I) cannot be classified as a class I device because insufficient information exists to determine that the controls authorized by or under sections 351, 352, 360, 360f, 360h, 360i, and 360j of this title are sufficient to provide reasonable assurance of the safety and effectiveness of the device and (II) cannot be classified as a class II device because insufficient information exists for the establishment of a performance standard to provide reasonable assurance of its safety and effectiveness, and”.Subsec. (e). Pub. L. 101-629, §5(b), designated existing provisions as par. (1), redesignated cls. (1) and (2) as (A) and (B), respectively, and added par. (2).Subsec. (f). Pub. L. 101-629, §5(c)(3), inserted “and reclassification” before “of” in heading.Subsec. (f)(2)(A). Pub. L. 101-629, §5(c)(1), substituted “The Secretary may initiate the reclassification of a device classified into class III under paragraph (1) of this subsection or the manufacturer” for “The manufacturer”.Subsec. (f)(2)(B)(i). Pub. L. 101-629, §18(a), substituted “the Secretary may for good cause shown” for “the Secretary shall”.Subsec. (f)(3). Pub. L. 101-629, §4(a), added par. (3).Subsec. (i). Pub. L. 101-629, §12(a), 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. regulations Section 12(b) of Pub. L. 101-629 provided that: “Within 12 months of the date of the enactment of this Act [Nov. 28, 1990], the Secretary of Health and Human Services shall issue regulations establishing the requirements of the summaries under section 513(i)(3) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360c(i)(3)], as added by the amendment made by subsection (a).” false false false

Part A Drugs and Devices Title 21 Section 360c(a)(1)(C) Title 21 Section 360c(i)(3) Title 21 Section 360j 21 U.S.C. 360c(a)(1)(C) 21 U.S.C. 360c(i)(3) 21 U.S.C. 360j Volume 86 Page 770 86 Stat. 770 Volume 90 Page 540 90 Stat. 540 Volume 90 Page 539 90 Stat. 539 Volume 104 Page 4515 104 Stat. 4515 Volume 106 Page 240 106 Stat. 240 Volume 107 Page 778 107 Stat. 778 Volume 111 Page 2336 111 Stat. 2336 Volume 116 Page 1613 116 Stat. 1613 Public Law 92-463 Public Law 94-295 Public Law 94-295 Public Law 101-509 Public Law 101-629 Public Law 101-629 Public Law 102-300 Public Law 102-300 Public Law 103-80 Public Law 103-80 Public Law 105-115 Public Law 105-115 Public Law 107-250 Public Law 107-250 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