2007—Subsec. (c)(1)(G), (H). Pub. L. 110–85 added subpar. (G) and redesignated former subpar. (G) as (H).

2004—Subsec. (c)(3). Pub. L. 108–214, § 2(d)(1)(B), amended directory language of Pub. L. 107–250, § 210. See 2002 Amendment note below.

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).

Subsec. (c)(4). 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).

2002—Subsec. (a). Pub. L. 107–250, § 302(c)(1), inserted “or, as applicable, an approval under subsection (c)(2) of this section of a report seeking premarket approval” before period in concluding provisions.

Subsec. (c)(2). Pub. L. 107–250, § 302(c)(2)(B), added par. (2). Former par. (2) redesignated (3).

Subsec. (c)(3). Pub. L. 107–250, § 302(c)(2)(A), redesignated par. (2) relating to Secretary’s referral of application to appropriate panel as (3).

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).

Pub. L. 107–250, § 209, added par. (3) relating to acceptance and review of any portion of the application prior to submission.

1997—Subsec. (d)(1)(A). 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 safety and effectiveness, if the proposed labeling is neither false nor misleading. In determining whether or not such labeling is false or misleading, the Secretary shall fairly evaluate all material facts pertinent to the proposed labeling.”

Subsec. (d)(1)(B)(iii). Pub. L. 105–115, § 201(b), added cl. (iii).

Subsec. (d)(3), (4). Pub. L. 105–115, § 202(1), 209 (b), added par. (3) and redesignated former par. (3) as (4).

Subsec. (d)(5). Pub. L. 105–115, § 202(2), added par. (5).

Subsec. (d)(6). Pub. L. 105–115, § 205(c)(2), added par. (6).

Subsec. (f)(2). 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.”

1993—Subsec. (c)(2)(A). Pub. L. 103–80 struck out “refer such application” after “own initiative”.

1990—Subsec. (c)(2). Pub. L. 101–629, § 18(c), substituted “the Secretary—” for “the Secretary shall” and added subpars. (A) and (B).

Subsec. (e). Pub. L. 101–629, § 9(a)(2), inserted “and temporary suspension” after “Withdrawal” in heading.

Subsec. (e)(3). Pub. L. 101–629, § 9(a)(1), added par. (3).

Subsec. (i). Pub. L. 101–629, § 4(b)(1), added subsec. (i).

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.

Advisory committees in existence on Jan. 5, 1973, to terminate not later than the expiration of the 2-year period following Jan. 5, 1973, and advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a committee established by Congress, its duration is otherwise provided by law. See section 14 of Pub. L. 92–463, Oct. 6, 1972, 86 Stat. 776, set out in the Appendix to Title 5, Government Organization and Employees.

Pub. L. 107–250, title II, § 205, Oct. 26, 2002, 116 Stat. 1612, directed the Secretary of Health and Human Services, not later than one year after Oct. 26, 2002, to report to the appropriate committees of Congress on the timeliness and effectiveness of device premarket reviews by centers other than the Center for Devices and Radiological Health, including information on the times required to log in and review original submissions and supplements, times required to review manufacturers’ replies to submissions, times to approve or clear such devices, and recommendations on improvement of performance and reassignment of responsibility for regulating such devices.

References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, § 101(c)(1)] of Pub. L. 101–509, set out in a note under section 5376 of Title 5.