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. 360d D09002ee180df8153-USCODE-2010-title21-chap9-subchapV-partA-sec360d.htm D09002ee180df8154-USCODE-2010-title21-chap9-subchapV-partA-sec360d.pdf http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partA-sec360d 21USC360d http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partA-sec360d/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapV-partA-sec360d.pdf http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partA-sec360d.htm 21 U.S.C. 360d 21 USC 360d 21 U.S.C. 360d 21 USC 360d; FOOD AND DRUGS; Performance standards 205 LEAF USCODE-2010-title21-chap9-subchapV-partA-sec360d Sec. 360d section standard June 25, 1938, ch. 675, §514, as added Pub. L. 94-295, §2, May 28, 1976, 90 Stat. 546; amended Pub. L. 94-460, title III, §304, Oct. 8, 1976, 90 Stat. 1960; Pub. L. 101-629, §§6(a), (b)(1), 18(b), Nov. 28, 1990, 104 Stat. 4519, 4528; Pub. L. 102-300, §6(g), June 16, 1992, 106 Stat. 241; Pub. L. 103-80, §4(a)(1), Aug. 13, 1993, 107 Stat. 779; Pub. L. 105-115, title II, §204(a), (d), Nov. 21, 1997, 111 Stat. 2335, 2336. amendments <b>1997</b>-Subsec. (a)(1). Pub. L. 105-115, §204(d)(1), substituted “under subsection (b) of this section” for “under this section”.Subsec. (a)(2). Pub. L. 105-115, §204(d)(2), substituted “under subsection (b) of this section” for “under this section” in introductory provisions.Subsec. (a)(3). Pub. L. 105-115, §204(d)(3), substituted “under subsection (b) of this section” for “under this section”.Subsec. (a)(4). Pub. L. 105-115, §204(d)(4), substituted “this subsection and subsection (b) of this section” for “this section” in introductory provisions.Subsec. (c). Pub. L. 105-115, §204(a), added subsec. (c).<b>1993</b>-Subsec. (b)(4)(B), (5)(A)(ii). Pub. L. 103-80 amended directory language of Pub. L. 101-619, §18(b), identical to amendment by Pub. L. 102-300, §6(g)(1). See 1992 and 1990 Amendment notes below.<b>1992</b>-Subsec. (b)(4)(B), (5)(A)(ii). Pub. L. 102-300 made technical corrections to directory language of Pub. L. 101-629, §18(b)(1), (2). See 1990 Amendment note below.<b>1990</b>-Subsec. (a)(1). Pub. L. 101-629, §6(a)(1), substituted “The special controls required by section 360c(a)(1)(B) of this title shall include performance standards for a class II device if the Secretary determines that a performance standard is necessary to provide reasonable assurance of the safety and effectiveness of the device.” for “The Secretary may by regulation, promulgated in accordance with this section, establish a performance standard for a class II device.”Subsec. (b). Pub. L. 101-629, §6(a)(2), (3), redesignated subsec. (g) as (b) and struck out former subsec. (b) which read as follows:“(1) A proceeding for the development of a performance standard for a device shall be initiated by the Secretary by the publication in the Federal Register of notice of the opportunity to submit to the Secretary a request (within fifteen days of the date of the publication of the notice) for a change in the classification of the device based on new information relevant to its classification.“(2) If, after publication of a notice pursuant to paragraph (1) the Secretary receives a request for a change in the device's classification, he shall, within sixty days of the publication of such notice and after consultation with the appropriate panel under section 360c of this title, by order published in the Federal Register, either deny the request for change in classification or give notice of his intent to initiate such a change under section 360c(e) of this title.”Subsec. (b)(1), (2). Pub. L. 101-629, §6(a)(4), amended pars. (1) and (2) generally. Prior to amendment, pars. (1) and (2) read as follows:“(1)(A) After publication pursuant to subsection (c) of this section of a notice respecting a performance standard for a device, the Secretary shall either-“(B) If the Secretary issues under subparagraph (A)(ii) a notice of termination of a proceeding to establish a performance standard for a device, he shall (unless such notice is issued because the device is a banned device under section 360f of this title) initiate a proceeding under section 360c(e) of this title to reclassify the device subject to the proceeding terminated by such notice.“(2) A notice of proposed rulemaking for the establishment of a performance standard for a device published under paragraph (1)(A)(i) shall set forth proposed findings with respect to the degree of the risk of illness or injury designed to be eliminated or reduced by the proposed standard and the benefit to the public from the device.”Subsec. (b)(3)(A)(i). Pub. L. 101-629, §6(b)(1)(A), substituted “paragraph (1)” for “paragraph (2)”.Subsec. (b)(4)(A). Pub. L. 101-629, §6(b)(1)(B), substituted “paragraphs (1), (2), and (3)(B)” for “paragraphs (2) and (3)(B)”.Subsec. (b)(4)(B). Pub. L. 101-629, §18(b)(1), as amended by Pub. L. 102-300, §6(g)(1), (2), and Pub. L. 103-80, §4(a)(1), struck out “,after affording all interested persons an opportunity for an informal hearing,” after “if he determines”.Subsec. (b)(5)(A)(ii). Pub. L. 101-629, §18(b)(2), as amended by Pub. L. 102-300, §6(g)(1), (3), and Pub. L. 103-80, §4(a)(1), substituted “which demonstrates good cause for referral and which is made before the expiration of the period for submission of comments on such proposed regulation refer such proposed regulation,” for “unless the Secretary finds the request to be without good cause or the request is made after the expiration of the period for submission of comments on such proposed regulation refer such proposed regulation,”.Subsecs. (c) to (f). Pub. L. 101-629, §6(a)(2), struck out subsec. (c) relating to invitations for standards, subsec. (d) relating to acceptance of certain existing standards, subsec. (e) relating to acceptance of offers to develop standards, and subsec. (f) relating to development of standards by the Secretary after publication of notice inviting submissions or offers of standards.Subsec. (g). Pub. L. 101-629, §6(a)(3), redesignated subsec. (g) as (b).<b>1976</b>-Subsec. (a). Pub. L. 94-460 redesignated pars. (4) and (5) as (3) and (4), respectively. Section as originally enacted contained no par. (3). 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 546 Volume 90 Page 1960 90 Stat. 546 90 Stat. 1960 Volume 104 Page 4519 104 Stat. 4519 Volume 106 Page 241 106 Stat. 241 Volume 107 Page 779 107 Stat. 779 Volume 111 Page 2335 111 Stat. 2335 Public Law 92-463 Public Law 94-295 Public Law 94-460 Public Law 94-460 Public Law 101-509 Public Law 101-619 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 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