21 U.S.C. 360j: General provisions respecting control of devices intended for human use

2022

• Pub. L. 117–286 substituted "Section 1013 of title 5" for "Section 14 of the Federal Advisory Committee Act" in concluding provisions. Law text · (f)
• Pub. L. 117–328, §3601(b), added par. (9). (Consolidated Appropriations Act, 2023) Law text · (g)
• Pub. L. 117–328, §3103, substituted "October 1, 2027" for "December 24, 2022". (Consolidated Appropriations Act, 2023) Law text · (m)
• Pub. L. 117–229 substituted "December 24, 2022" for "December 17, 2022". (Further Continuing Appropriations and Extensions Act, 2023) Law text · (m)
• Pub. L. 117–180 substituted "December 17" for "October 1". (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (m)

2017

• Pub. L. 115–52, §502(b)(1)(B), inserted "or an appropriate local committee" after "review committee" in two places in concluding provisions. (FDA Reauthorization Act of 2017) Law text · (m)
• Pub. L. 115–52, §502(b)(1)(A), inserted "or an appropriate local committee" after "review committee" in two places. (FDA Reauthorization Act of 2017) Law text · (m)
• Pub. L. 115–52, §502(b)(2), substituted "2022" for "2017". (FDA Reauthorization Act of 2017) Law text · (m)
• Pub. L. 115–52, §706(a), added subsec. (p). (FDA Reauthorization Act of 2017) Law text · (p)
• Pub. L. 115–52, §709(a), added subsec. (q). Amendment was executed to this section as amended by section 706(a) of Pub. L. 115–52, notwithstanding directory language referring to section as amended by section 708 of Pub. L. 115–52, which did not amend this section. (FDA Reauthorization Act of 2017) Law text · (q)

2016

• Pub. L. 114–255, §3024(a)(2), substituted "subparagraph (D)(ii)" for "subparagraph (D)" in concluding provisions. (21st Century Cures Act) Law text · (g)
• Pub. L. 114–255, §3056(1)(A), struck out "local" before "institutional review committee" and "which has been" before "established in accordance with". (21st Century Cures Act) Law text · (g)
• Pub. L. 114–255, §3056(1)(B), substituted "an institutional" for "a local institutional". (21st Century Cures Act) Law text · (g)
• Pub. L. 114–255, §3024(a)(1), substituted "except where, subject to such conditions as the Secretary may prescribe—" for "except where subject to such conditions as the Secretary may prescribe,", added cl. (i), and inserted cl. (ii) designation before "the investigator". (21st Century Cures Act) Law text · (g)
• Pub. L. 114–255, §3038(b)(1), substituted "Subject to subparagraph (C), any information" for "Any information" in introductory provisions. (21st Century Cures Act) Law text · (h)
• Pub. L. 114–255, §3038(b)(2), added subpar. (C). (21st Century Cures Act) Law text · (h)
• Pub. L. 114–255, §3052(a)(1), substituted "not more than 8,000" for "fewer than 4,000". (21st Century Cures Act) Law text · (m)
• Pub. L. 114–255, §3052(a)(2), substituted "not more than 8,000" for "fewer than 4,000". (21st Century Cures Act) Law text · (m)
• Pub. L. 114–255, §3056(2)(C), struck out "local" after "chairperson of the" in concluding provisions. (21st Century Cures Act) Law text · (m)
• Pub. L. 114–255, §3056(2)(A), added subpar. (A) and struck out former subpar. (A) which read as follows: "in facilities that have established, in accordance with regulations of the Secretary, a local institutional review committee to supervise clinical testing of devices in the f… (21st Century Cures Act) Law text · (m)
• Pub. L. 114–255, §3056(2)(B), substituted "an institutional" for "a local institutional". (21st Century Cures Act) Law text · (m)
• Pub. L. 114–255, §3052(a)(3), substituted "8,000" for "4,000". (21st Century Cures Act) Law text · (m)
• Pub. L. 114–255, §3060(a), added subsec. (o). (21st Century Cures Act) Law text · (o)

2012

• Pub. L. 112–144, §617, amended subsec. (b) generally. Prior to amendment, subsec. (b) related to custom devices. (Food and Drug Administration Safety and Innovation Act) Law text · (b)
• Pub. L. 112–144, §601(1), inserted "safety or effectiveness" before "data obtained". (Food and Drug Administration Safety and Innovation Act) Law text · (g)
• Pub. L. 112–144, §601(2), added subpar. (C). (Food and Drug Administration Safety and Innovation Act) Law text · (g)
• Pub. L. 112–144, §606, added par. (8). (Food and Drug Administration Safety and Innovation Act) Law text · (g)
• Pub. L. 112–144, §613(a)(1)(A)(i), added cl. (i) and struck out former cl. (i) which read as follows: (Food and Drug Administration Safety and Innovation Act) Law text · (m)
• Pub. L. 112–144, §613(a)(1)(A)(ii), added cl. (ii) and struck out former cl. (ii) which read as follows: "During any calendar year, the number of such devices distributed during that year does not exceed the annual distribution number specified by the Secretary when the Secre… (Food and Drug Administration Safety and Innovation Act) Law text · (m)
• Pub. L. 112–144, §507(c), substituted "2017" for "2012". (Food and Drug Administration Safety and Innovation Act) Law text · (m)
• Pub. L. 112–144, §613(a)(1)(B), amended subpar. (C) generally. Prior to amendment, subpar. (C) read as follows: "A person may petition the Secretary to modify the annual distribution number specified by the Secretary under subparagraph (A)(ii) with respect to a device if addition… (Food and Drug Administration Safety and Innovation Act) Law text · (m)
• Pub. L. 112–144, §613(a)(2), substituted "regarding a device described in paragraph (6)(A)(i)(I)" for "regarding a device". (Food and Drug Administration Safety and Innovation Act) Law text · (m)
• Pub. L. 112–144, §613(a)(3), substituted "of all devices described in paragraph (6)(A)(i)(I)" for "of all devices described in paragraph (6)". (Food and Drug Administration Safety and Innovation Act) Law text · (m)

2007

• Pub. L. 110–85, §801(b)(3)(E), inserted before period at end of first sentence of concluding provisions "and such application shall include the certification required under section 282(j)(5)(B) of title 42 (which shall not be considered an element of such application)". (Food and Drug Administration Amendments Act of 2007) Law text · (m)
• Pub. L. 110–85, §303(a)(1), substituted "Except as provided in paragraph (6), no" for "No". (Food and Drug Administration Amendments Act of 2007) Law text · (m)
• Pub. L. 110–85, §303(a)(2), inserted ", if the Secretary has reason to believe that the requirements of paragraph (6) are no longer met," after "public health" and inserted at end "If the person granted an exemption under paragraph (2) fails to demonstrate continued compliance with … (Food and Drug Administration Amendments Act of 2007) Law text · (m)
• Pub. L. 110–85, §303(a)(3), added pars. (6) to (8) and struck out former par. (6) which read as follows: "The Secretary may suspend or withdraw an exemption from the effectiveness requirements of sections 360d and 360e of this title for a humanitarian device only after provid… (Food and Drug Administration Amendments Act of 2007) Law text · (m)

2005

• Pub. L. 109–96 added subsec. (n). Law text · (n)

1997

• Pub. L. 105–115, §410(a), added cl. (iii). (Food and Drug Administration Modernization Act of 1997) Law text · (f)
• Pub. L. 105–115, §201(a), added pars. (6) and (7). (Food and Drug Administration Modernization Act of 1997) Law text · (g), (7)
• Pub. L. 105–115, §216(a)(1), amended par. (4) generally. Prior to amendment, par. (4) related to premarket approval of devices. (Food and Drug Administration Modernization Act of 1997) Law text · (h)
• Pub. L. 105–115, §125(b)(2)(E), struck out "or antibiotic drugs" after "new drugs" in heading. (Food and Drug Administration Modernization Act of 1997) Law text · (l)
• Pub. L. 105–115, §125(b)(2)(E), struck out par. (4) which read as follows: "Any device intended for human use which on the enactment date was subject to the requirements of section 357 of this title shall be subject to such requirements as follows: (Food and Drug Administration Modernization Act of 1997) Law text · (l)
• Pub. L. 105–115, §203(1), inserted at end "The request shall be in the form of an application submitted to the Secretary. Not later than 75 days after the date of the receipt of the application, the Secretary shall issue an order approving or denying the application." (Food and Drug Administration Modernization Act of 1997) Law text · (m)
• Pub. L. 105–115, §203(2)(B), inserted at end "In a case described in subparagraph (B) in which a physician uses a device without an approval from an institutional review committee, the physician shall, after the use of the device, notify the chairperson of the local institutional re… (Food and Drug Administration Modernization Act of 1997) Law text · (m)
• Pub. L. 105–115, §203(2)(A), inserted before period at end ", unless a physician determines in an emergency situation that approval from a local institutional review committee can not be obtained in time to prevent serious harm or death to a patient". (Food and Drug Administration Modernization Act of 1997) Law text · (m)
• Pub. L. 105–115, §203(3), amended par. (5) generally. Prior to amendment, par. (5) read as follows: "An exemption under paragraph (2) shall be for a term of 18 months and may only be initially granted in the 5-year period beginning on the date regulations under paragraph (6) take ef… (Food and Drug Administration Modernization Act of 1997) Law text · (m)
• Pub. L. 105–115, §203(4), amended par. (6) generally. Prior to amendment, par. (6) read as follows: "Within one year of November 28, 1990, the Secretary shall issue regulations to implement this subsection." (Food and Drug Administration Modernization Act of 1997) Law text · (m)

1992

• Pub. L. 102–571 substituted "379e" for "376". · (g)

1990

• Pub. L. 101–629, §11(1), substituted "from class III to class II or class I" for "under section 360c of this title from class III to class II" and inserted "(1) in accordance with subsection (h), and (2)" after "except". · (c)
• Pub. L. 101–629, §18(e), inserted "pre-production design validation (including a process to assess the performance of a device but not including an evaluation of the safety or effectiveness of a device)," after "manufacture,". · (f)
• Pub. L. 101–629, §11(2)(A), substituted "Except as provided in paragraph (4), any" for "Any". · (h)
• Pub. L. 101–629, §11(2)(B), added par. (4). · (h)
• Pub. L. 101–629, §6(b)(2), substituted "section 360d(b)(5)(B)" for "section 360d(g)(5)(B)". · (i)
• Pub. L. 101–629, §3(b)(2), substituted "Except as provided in section 360i(e) of this title, no" for "No". · (j)
• Pub. L. 101–629, §18(f), struck out "and after affording the petitioner an opportunity for an informal hearing" after "under this paragraph". · (l)
• Pub. L. 101–629, §5(c)(2), 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". · (l)
• Pub. L. 101–629, §4(b)(2), added par. (5). · (l)
• Pub. L. 101–629, §14(a), added subsec. (m). · (m)