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. 360l D09002ee180df8153-USCODE-2010-title21-chap9-subchapV-partA-sec360l.htm D09002ee180df8154-USCODE-2010-title21-chap9-subchapV-partA-sec360l.pdf http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partA-sec360l 21USC360l http://www.gpo.gov/fdsys/granule/USCODE-2010-title21/USCODE-2010-title21-chap9-subchapV-partA-sec360l/content-detail.html http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapV-partA-sec360l.pdf http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapV-partA-sec360l.htm 21 U.S.C. 360l 21 USC 360l 21 U.S.C. 360l 21 USC 360l; FOOD AND DRUGS; Postmarket surveillance 214 LEAF USCODE-2010-title21-chap9-subchapV-partA-sec360l Sec. 360l section standard June 25, 1938, ch. 675, §522, as added Pub. L. 101-629, §10, Nov. 28, 1990, 104 Stat. 4521; amended Pub. L. 102-300, §3(b), June 16, 1992, 106 Stat. 239; Pub. L. 105-115, title II, §212, Nov. 21, 1997, 111 Stat. 2346; Pub. L. 110-85, title III, §307, Sept. 27, 2007, 121 Stat. 865. amendments <b>2007</b>-Pub. L. 110-85, §307(1), made technical amendment to section catchline.Subsec. (a). Pub. L. 110-85, §307(2), added subsec. (a) and struck out former subsec. (a). Prior to amendment, text read as follows: “The Secretary may by order require a manufacturer to conduct postmarket surveillance for any device of the manufacturer which is a class II or class III device the failure of which would be reasonably likely to have serious adverse health consequences or which is intended to be-Subsec. (b). Pub. L. 110-85, §307(3), designated existing provisions as par. (1), inserted par. heading, substituted “Except as provided in paragraph (2), the Secretary, in consultation” for “The Secretary, in consultation” and “Except as provided in paragraph (2), any determination” for “Any determination”, and added par. (2).Subsec. (c). Pub. L. 110-85, §307(3)(D), added subsec. (c).<b>1997</b>-Pub. L. 105-115 amended section generally, substituting present provisions for former provisions which related to required surveillance, discretionary surveillance, and surveillance approval.<b>1992</b>-Subsec. (b). Pub. L. 102-300 substituted “(a)(1)” for “(a)”, inserted comma after “commerce”, and inserted after first sentence “Each manufacturer required to conduct a surveillance of a device under subsection (a)(2) of this section shall, within 30 days after receiving notice that the manufacturer is required to conduct such surveillance, submit, for the approval of the Secretary, a protocol for the required surveillance.” effectiveDate amendments Section 212 of Pub. L. 105-115 provided in part that the amendment made by that section is effective 90 days after Nov. 21, 1997. false false false

Part A Drugs and Devices Title 21 Section 301et seq. 21 U.S.C. 301et seq. Volume 104 Page 4521 104 Stat. 4521 Volume 106 Page 239 106 Stat. 239 Volume 111 Page 2346 111 Stat. 2346 Volume 116 Page 1614 116 Stat. 1614 Volume 118 Page 577 118 Stat. 577 Volume 121 Page 865 121 Stat. 865 Public Law 101-629 Public Law 102-300 Public Law 102-300 Public Law 105-115 Public Law 105-115 Public Law 107-250 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