21 U.S.C. 360e: Premarket approval

2022

• Pub. L. 117–328 substituted "Unless the change is consistent with a predetermined change control plan approved under section 360e–4 of this title, a supplemental" for "A supplemental". (Consolidated Appropriations Act, 2023) Law text · (d)

2017

• Pub. L. 115–52 substituted "section 379j(g)" for "section 379j(h)". (FDA Reauthorization Act of 2017) Law text · (c)

2016

• Pub. L. 114–255, §3101(a)(2)(J), substituted "subject to an order" for "subject to a an order". (21st Century Cures Act) Law text · (a)
• Pub. L. 114–255, §3058(b), added par. (5). (21st Century Cures Act) Law text · (c)
• Pub. L. 114–255, §3051(c)(1), redesignated par. (6) as (5) and struck out former par. (5) which read as follows: "In order to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions, the Secretary shall pro… (21st Century Cures Act) Law text · (d), (6)

2012

• Pub. L. 112–144, §608(b)(1)(A), substituted "an order issued under subsection (b) (or a regulation promulgated under such subsection prior to July 9, 2012)" for "regulation promulgated under subsection (b)". (Food and Drug Administration Safety and Innovation Act) Law text · (a)
• Pub. L. 112–144, §608(b)(1)(B)(i)(I), which directed substitution of "Order" for "Regulation" in the heading of par. (1) of subsec. (b), was executed by making the substitution in the heading of subsec. (b), to reflect the probable intent of Congress. (Food and Drug Administration Safety and Innovation Act) Law text · (b)
• Pub. L. 112–144, §608(b)(1)(B)(i)(II), in concluding provisions, substituted "by administrative order following publication of a proposed order in the Federal Register, a meeting of a device classification panel described in section 360c(b) of this title, and consideration of commen… (Food and Drug Administration Safety and Innovation Act) Law text · (b)
• Pub. L. 112–144, §608(b)(1)(B)(ii), struck out subpar. (A) designation after "(2)" and substituted "A proposed order required under paragraph (1) shall contain—" for "A proceeding for the promulgation of a regulation under paragraph (1) respecting a device shall be initiated by the … (Food and Drug Administration Safety and Innovation Act) Law text · (b)
• Pub. L. 112–144, §608(b)(1)(B)(iii)(I), (II), (IV), (V), substituted "proposed order" for "proposed regulation" in two places, "paragraph (2)," for "paragraph (2) and after", "(A) issue an administrative order under paragraph (1)" for "(A) promulgate such regulation", "paragraph (2)… (Food and Drug Administration Safety and Innovation Act) Law text · (b)
• Pub. L. 112–144, §608(b)(1)(B)(iii)(III), which directed insertion of "and a meeting of a device classification panel described in section 360c(b) of this title," after "such proposed regulation and findings," was inserted after "such proposed order and findings," to reflect the probable intent of … (Food and Drug Administration Safety and Innovation Act) Law text · (b)
• Pub. L. 112–144, §608(b)(1)(B)(iv), struck out par. (4) which read as follows: "The Secretary, upon his own initiative or upon petition of an interested person, may by regulation amend or revoke any regulation promulgated under this subsection. A regulation to amend or revoke a regu… (Food and Drug Administration Safety and Innovation Act) Law text · (b)
• Pub. L. 112–144, §203(g), substituted "379j(h)" for "379j(g)". (Food and Drug Administration Safety and Innovation Act) Law text · (c)
• Pub. L. 112–144, §608(b)(1)(C)(i)(III), (IV), in concluding provisions, substituted "administrative order issued under this paragraph requires" for "regulation requires" and struck out at end "Before the publication of a regulation requiring a device to remain in class III or revisi… (Food and Drug Administration Safety and Innovation Act) Law text · (i)
• Pub. L. 112–144, §608(b)(1)(C)(i)(I), in introductory provisions, substituted "the date that is 2 years after July 9, 2012" for "December 1, 1995" and "issue an administrative order following publication of a proposed order in the Federal Register, a meeting of a device classification panel describ… (Food and Drug Administration Safety and Innovation Act) Law text · (i)
• Pub. L. 112–144, §608(b)(1)(C)(i)(II), substituted "administrative order has been issued under subsection (b) (or no regulation has been promulgated under such subsection prior to July 9, 2012)" for "final regulation has been promulgated under subsection (b) of this section". (Food and Drug Administration Safety and Innovation Act) Law text · (i)
• Pub. L. 112–144, §608(b)(1)(C)(ii), substituted "order requiring" for "regulation requiring" in two places and "issuance of an administrative order under subsection (b)" for "promulgation of a subsection (b) of this section regulation". (Food and Drug Administration Safety and Innovation Act) Law text · (i)

2007

• Pub. L. 110–85 added subpar. (G) and redesignated former subpar. (G) as (H). (Food and Drug Administration Amendments Act of 2007) Law text · (c), (H)

2004

• Pub. L. 108–214, §2(d)(1)(B), amended directory language of Pub. L. 107–250, §210. See 2002 Amendment note below. Law text · (c)
• Pub. L. 108–214, §2(d)(1)(A)(i), redesignated par. (3) relating to acceptance and review of any portion of the application prior to submission as (4). Law text · (c)
• Pub. L. 108–214, §2(d)(1)(A), redesignated par. (3) relating to acceptance and review of any portion of the application prior to submission as (4) and substituted "unless a significant issue of safety" for "unless an issue of safety" in subpar. (B). Law text · (c)

2002

• Pub. L. 107–250, §302(c)(1), inserted "or, as applicable, an approval under subsection (c)(2) of a report seeking premarket approval" before period in concluding provisions. (Medical Device User Fee and Modernization Act of 2002) Law text · (a)
• Pub. L. 107–250, §302(c)(2)(B), added par. (2). Former par. (2) redesignated (3). (Medical Device User Fee and Modernization Act of 2002) Law text · (c)
• Pub. L. 107–250, §302(c)(2)(A), redesignated par. (2) relating to Secretary's referral of application to appropriate panel as (3). (Medical Device User Fee and Modernization Act of 2002) Law text · (c)
• Pub. L. 107–250, §210, as amended by Pub. L. 108–214, §2(d)(1)(B), inserted "Where appropriate, the Secretary shall ensure that such panel includes, or consults with, one or more pediatric experts." at the end of the concluding provisions of par. (3) as redesignated by Pub. L. 107–250, §302(c)(2)(A… (Medical Device User Fee and Modernization Act of 2002) Law text · (c)
• Pub. L. 107–250, §209, added par. (3) relating to acceptance and review of any portion of the application prior to submission. (Medical Device User Fee and Modernization Act of 2002) Law text · (c)

1997

• Pub. L. 105–115, §205(c)(1), inserted at end "In making the determination whether to approve or deny the application, the Secretary shall rely on the conditions of use included in the proposed labeling as the basis for determining whether or not there is a reasonable assurance of… (Food and Drug Administration Modernization Act of 1997) Law text · (d)
• Pub. L. 105–115, §201(b), added cl. (iii). (Food and Drug Administration Modernization Act of 1997) Law text · (d)
• Pub. L. 105–115, §202(1), 209(b), added par. (3) and redesignated former par. (3) as (4). (Food and Drug Administration Modernization Act of 1997) Law text · (d), (4)
• Pub. L. 105–115, §202(2), added par. (5). (Food and Drug Administration Modernization Act of 1997) Law text · (d)
• Pub. L. 105–115, §205(c)(2), added par. (6). (Food and Drug Administration Modernization Act of 1997) Law text · (d)
• Pub. L. 105–115, §216(b), substituted "the Secretary—" and subpars. (A) and (B) for "he shall refer the proposed protocol to the appropriate panel under section 360c of this title for its recommendation respecting approval of the protocol." (Food and Drug Administration Modernization Act of 1997) Law text · (f)

1993

• Pub. L. 103–80 struck out "refer such application" after "own initiative". · (c)

1990

• Pub. L. 101–629, §18(c), substituted "the Secretary—" for "the Secretary shall" and added subpars. (A) and (B). · (c)
• Pub. L. 101–629, §9(a)(2), inserted "and temporary suspension" after "Withdrawal" in heading. · (e)
• Pub. L. 101–629, §9(a)(1), added par. (3). · (e)
• Pub. L. 101–629, §4(b)(1), added subsec. (i). · (i)