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. 360i D09002ee180df8153-USCODE-2010-title21-chap9-subchapV-partA-sec360i.htm D09002ee180df8154-USCODE-2010-title21-chap9-subchapV-partA-sec360i.pdf http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partA-sec360i 21USC360i http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partA-sec360i/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapV-partA-sec360i.pdf http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partA-sec360i.htm 21 U.S.C. 360i 21 USC 360i 21 U.S.C. 360i 21 USC 360i; FOOD AND DRUGS; Records and reports on devices 211 LEAF USCODE-2010-title21-chap9-subchapV-partA-sec360i Sec. 360i section standard June 25, 1938, ch. 675, §519, as added Pub. L. 94-295, §2, May 28, 1976, 90 Stat. 564; amended Pub. L. 101-629, §§2(a), 3(a)(1), (b)(1), 7, Nov. 28, 1990, 104 Stat. 4511, 4513, 4514, 4520; Pub. L. 102-300, §5(a), June 16, 1992, 106 Stat. 239; Pub. L. 103-80, §3(u), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105-115, title II, §§211, 213(a), (c), Nov. 21, 1997, 111 Stat. 2345-2347; Pub. L. 110-85, title II, §§226(a), 227, Sept. 27, 2007, 121 Stat. 854. amendments <b>2007</b>-Subsec. (a)(1)(B). Pub. L. 110-85, §227, substituted “were to recur, which report under this subparagraph-” for “were to recur;” and added cls. (i) to (iii).Subsecs. (f), (g). Pub. L. 110-85, §226(a), added subsec. (f) and redesignated former subsec. (f) as (g).<b>1997</b>-Subsec. (a). Pub. L. 105-115, §213(a)(1)(A), (F), in introductory provisions, substituted “manufacturer or importer” for “manufacturer, importer, or distributor” and, in closing provisions, inserted at end “The Secretary shall by regulation require distributors to keep records and make such records available to the Secretary upon request. Paragraphs (4) and (8) apply to distributors to the same extent and in the same manner as such paragraphs apply to manufacturers and importers.”Subsec. (a)(4). Pub. L. 105-115, §213(a)(1)(B), substituted “manufacturer or importer” for “manufacturer, importer, or distributor”.Subsec. (a)(7). Pub. L. 105-115, §213(a)(1)(C), inserted “and” after semicolon at end.Subsec. (a)(8). Pub. L. 105-115, §213(a)(1)(D), substituted “manufacturer or importer” for “manufacturer, importer, or distributor” wherever appearing and substituted period for semicolon after “misbranded”.Subsec. (a)(9). Pub. L. 105-115, §213(a)(1)(E), struck out par. (9) which read as follows: “shall require distributors who submit such reports to submit copies of the reports to the manufacturer of the device for which the report was made.”Subsec. (b)(1)(C). Pub. L. 105-115, §213(c)(1)(A), in introductory provisions, substituted “on an annual basis” for “on a semi-annual basis” and struck out “and July 1” after “January 1” and struck out closing provisions which read as follows: “The Secretary may by regulation alter the frequency and timing of reports required by this subparagraph.”Subsec. (b)(2)(A). Pub. L. 105-115, §213(c)(1)(B)(i), inserted “or” after comma at end.Subsec. (b)(2)(B). Pub. L. 105-115, §213(c)(1)(B)(ii), substituted period for “,or” at end.Subsec. (b)(2)(C). Pub. L. 105-115, §213(c)(1)(B)(iii), struck out subpar. (C) which read as follows: “a disclosure required under subsection (a) of this section.”Subsec. (b)(5), (6). Pub. L. 105-115, §213(c)(2), added par. (5) and redesignated former par. (5) as (6).Subsec. (d). Pub. L. 105-115, §213(a)(2), struck out heading and text of subsec. (d). Text read as follows: “Each manufacturer, importer, and distributor required to make reports under subsection (a) of this section shall submit to the Secretary annually a statement certifying that-Subsec. (e). Pub. L. 105-115, §211, amended heading and text of subsec. (e) generally. Prior to amendment, text read as follows: “Every person who registers under section 360 of this title and is engaged in the manufacture of-Subsec. (f)(1). Pub. L. 105-115, §213(a)(3), substituted “or importer” for “,importer, or distributor” wherever appearing.<b>1993</b>-Subsec. (a). Pub. L. 103-80 substituted “paragraph (7)” for “paragraph (4)” in last sentence.<b>1992</b>-Subsec. (a). Pub. L. 102-300, §5(a)(1), added pars. (1) to (3) and redesignated former pars. (1) to (6) as (4) to (9), respectively.Subsec. (b)(1)(A). Pub. L. 102-300, §5(a)(2)(A), substituted “a device has or may have” for “there is a probability that a device has”.Subsec. (b)(1)(B). Pub. L. 102-300, §5(a)(2)(A), (B), substituted “a device has or may have” for “there is a probability that a device has”, designated existing provisions as cl. (i), and added cl. (ii).Subsec. (b)(5)(B)(iii). Pub. L. 102-300, §5(a)(2)(C), struck out “immediate” before “medical”.<b>1990</b>-Subsec. (a)(6). Pub. L. 101-629, §3(a)(1), added par. (6).Subsecs. (b), (c). Pub. L. 101-629, §2(a), added subsec. (b) and redesignated former subsec. (b) as (c).Subsecs. (d), (e). Pub. L. 101-629, §3(b)(1), added subsecs. (d) and (e).Subsec. (f). Pub. L. 101-629, §7, added subsec. (f). changeOfName Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999. effectiveDate amendments Section 211 of Pub. L. 105-115 provided in part that the amendment made by that section is effective 90 days after Nov. 21, 1997.Amendment by section 213(a), (c) of 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.Section 2(b) of Pub. L. 102-300 provided that: “The amendments made by subsection (a) [amending sections 3(b)(3) and 3(c) of Pub. L. 101-629, set out as notes below] shall take effect as of May 27, 1992 and any rule to implement section 519(e) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360i(e)] proposed under section 3(c)(2) of the Safe Medical Devices Act of 1990 [Pub. L. 101-629, set out as a note below] shall revert to its proposed status as of such date.”Section 5(b) of Pub. L. 102-300 provided that: “The amendments made by subsection (a) [amending this section] shall take effect-Section 2(c) of Pub. L. 101-629 provided that: “Section 519(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360i(b)], as added by the amendment made by subsection (a), shall take effect-Section 3(a)(2) of Pub. L. 101-629 provided that: “Section 519(a)(6) [21 U.S.C. 360i(a)(6)], as added by the amendment made by paragraph (1), shall take effect upon the effective date of final regulations under subsection (c) [set out below].”Section 3(b)(3) of Pub. L. 101-629, as amended by Pub. L. 102-300, §2(a)(1), June 16, 1992, 106 Stat. 238, provided that: “Section 519(e) [21 U.S.C. 360i(e)], as added by the amendment made by paragraph (1), shall take effect upon the expiration of 9 months after the issuance of final regulations under subsection (c) [set out below].”[For effective date of amendment by Pub. L. 102-300, see section 2(b) of Pub. L. 102-300, set out above as an Effective Date of 1992 Amendment note.] regulations Section 2(b) of Pub. L. 101-629 provided that: “The Secretary of Health and Human Services shall promulgate regulations to implement section 519(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360i(b)], as added by the amendment made by subsection (a) (including a definition of the summary required by paragraph (1)(C) of such section) not later than 12 months after the date of enactment of this Act [Nov. 28, 1990]. In promulgating the regulations, the Secretary shall minimize the administrative burdens on device user facilities consistent with the need to assure adequate information.”Section 3(c) of Pub. L. 101-629, as amended by Pub. L. 102-300, §2(a)(2), (3), June 16, 1992, 106 Stat. 238, provided that:“(1)(A) Not later than 9 months after the date of the enactment of this Act [Nov. 28, 1990], the Secretary of Health and Human Services shall issue proposed regulations-“(B) Regulations under subparagraph (A) shall-“(2) Not later than 18 months after the date of the enactment of this Act, the Secretary shall issue final regulations to implement sections [sic] 519(a)(6) of the Federal Food, Drug, and Cosmetic Act. If the Secretary does not promulgate such final regulations upon the expiration of such 18 months, the Congress finds that there is good cause for the proposed regulations to be considered as the final regulations without response to comment because the implementation of sections [sic] 519(a)(6) of such Act is essential to protect the health of patients who use such devices. Consequently, in such event, the proposed regulations issued under paragraph (1) shall become final regulations as of the expiration of such 18 months. There shall be promptly published in the Federal Register notice of the new status of the proposed regulations.“(3) Not later than November 28, 1992, the Secretary shall issue final regulations to implement section 519(e) of the Federal Food, Drug, and Cosmetic Act. If the Secretary does not promulgate such final regulations by November 28, 1992, the Congress finds that there is good cause for the proposed regulations to be considered as the final regulations without response to comment because the implementation of section 519(e) of such Act is essential to protect the health of patients who use devices. In such event, the proposed regulations issued under paragraph (1) shall become the issued final regulations on November 29, 1992. There shall be promptly published in the Federal Register notice of the new status of the proposed regulations.”[For effective date of amendment by Pub. L. 102-300, see section 2(b) of Pub. L. 102-300, set out above as an Effective Date of 1992 Amendment note.] false false false

Part A Drugs and Devices S. Res. 20 106 Title 21 Section 360i(a)(6) Title 21 Section 360i(b) Title 21 Section 360i(b)(5)(A) Title 21 Section 360i(e) 21 U.S.C. 360i(a)(6) 21 U.S.C. 360i(b) 21 U.S.C. 360i(b)(5)(A) 21 U.S.C. 360i(e) Volume 90 Page 564 90 Stat. 564 Volume 104 Page 4511 104 Stat. 4511 Volume 106 Page 239 106 Stat. 239 Volume 106 Page 238 106 Stat. 238 Volume 107 Page 778 107 Stat. 778 Volume 111 Page 2347 111 Stat. 2347 Volume 111 Page 2345-2347 111 Stat. 2345-2347 Volume 121 Page 854 121 Stat. 854 Public Law 94-295 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 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