Sec. 824. Enforcement and other provisions

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Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ), as amended by section 811, is further amended— in paragraphs (a), (b), (c), (g), (h), (k), (q), (r), and (y), by inserting in vitro clinical test, after device, each place it appears; in paragraph (g), by inserting after misbranded , , and the development within any Territory of any in vitro clinical test that is adulterated or misbranded ; in paragraph (y), by inserting or 587Q after section 523 each place it appears; in paragraph (ff), by striking or device and inserting , device, or in vitro clinical test ; and by adding at the end, the following:

Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp, tag, label, or other identification upon any in vitro clinical test or container, packaging, or labeling thereof so as to render such in vitro clinical test a counterfeit in vitro clinical test. Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark or imprint of another or any likeness of any of the foregoing upon any in vitro clinical test or container, packaging, or labeling thereof so as to render such in vitro clinical test a counterfeit in vitro clinical test.

The doing of any act which causes an in vitro clinical test to be a counterfeit in vitro clinical test, or the sale or dispensing, or the holding for sale or dispensing, of a counterfeit in vitro clinical test. The introduction or delivery for introduction into interstate commerce of an in vitro clinical test in violation of section 587B(a). The making of a false, fraudulent, or deceptive statement about an in vitro clinical test that is exempt from premarket review under section 587C.

The failure to maintain complete and accurate documentation for an exemption as required under section 587C or the failure to provide labeling required under section 587L. With respect to an in vitro clinical test, the submission of any report or listing under this Act that is false or misleading in any material respect. The failure to comply with a condition of approval, or restriction required under an approved application under section 587B; the failure to perform a risk analysis required by section 587B; the failure to submit an annual update required under section 587J(c)(2)(B); or the failure to complete postmarket surveillance as required under section 587X.

The failure to comply with applicable requirements to submit an application or report under section 587D(e). The failure to comply with applicable mitigating measures established under section 587E or to submit, maintain, or make available the documentation required under section 587E(b); or the failure to comply with applicable performance standards established under section 587R. The failure to register in accordance with section 587J, the failure to provide information required under section 587J(b), or the failure to maintain or submit information required under section 587J(c).

The failure to comply with requirements under section 587M or 587N, the failure to comply with a restriction required under section 587O, or the failure to comply with labeling and advertising requirements under section 587O(b). The failure to comply with the requirements of section 587Q. The failure to comply with any requirement of section 587S; the failure to furnish any notification, information, material, or report required under section 587S; or the failure to comply with an order issued under section 587S.

The failure to furnish information requested by the Secretary under 587G(d)(2). . Section 303 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 333 ) is amended— in subsection (b)(8), by inserting or counterfeit in vitro clinical test after counterfeit drug ; in subsection (c)— by striking ; or

(5)and inserting ;

(5); and by inserting before the period at the end the following: ; or

(6)for having violated section 301(fff)(2) if such person acted in good faith and had no reason to believe that use of the punch, die, plate, stone, or other thing involved would result in an in vitro clinical test being a counterfeit in vitro clinical test, or for having violated section 301(fff)(3) if the person doing the act or causing it to be done acted in good faith and had no reason to believe that the in vitro clinical test was a counterfeit in vitro clinical test ; and in subsection (f)(1)— in subparagraph (A)— by inserting or in vitro clinical tests after which relates to devices ; by inserting or section 587Q(a)(2) after section 704(g) ; and by inserting or in vitro clinical tests, as applicable before the period at the end of the second sentence; and in subparagraph (B)(i), by striking or 520(f) and inserting , 520(f), 587K, or 587M, . Section 304 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 334 ) is amended— in subsection (a)(2)— by striking , and

(E)and inserting ,

(E); and by inserting before the period at the end the following: , and

(F)Any in vitro clinical test that is a counterfeit in vitro clinical test,

(G)Any container, packaging, or labeling of a counterfeit in vitro clinical test, and

(H)Any punch, die, plate, stone, labeling, container, or other thing used or designed for use in making a counterfeit in vitro clinical test ; in subsection (d)(1), by inserting in vitro clinical test, after device, ; and in subsection (g)— in paragraph (1), by inserting , in vitro clinical test, after device each place it appears; and in paragraph (2)— in subparagraph (A), by inserting , in vitro clinical test, after device ; and in subparagraph (B), by inserting or in vitro clinical test after device each place it appears. Section 306 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 335a ) is amended by adding at the end the following: If the Secretary finds that a person has been convicted of a felony for a violation of section 301(gg) or 301(jjj)(1), the Secretary shall debar such person from being accredited under section 587Q and from carrying out activities under an agreement described in section 803(b). The Secretary shall debar a person under paragraph

(1)for the following periods: The period of debarment of a person (other than an individual) shall not be less than 1 year or more than 10 years, but if an act leading to a subsequent debarment under such paragraph occurs within 10 years after such person has been debarred under such paragraph, the period of debarment shall be permanent. The debarment of an individual shall be permanent. Subsections (c)(3), (d), (e), (i), (j), and (l)(1) apply with respect to a person (other than an individual) or an individual who is debarred under paragraph

(1)to the same extent and in the same manner as such subsections apply with respect to a person who is debarred under subsection (a)(1), or an individual who is debarred under subsection (a)(2), respectively. . Section 561 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb ) is amended— in subsections

(a)through (d)— by striking or investigational devices each place it appears and inserting , investigational devices, or investigational in vitro clinical tests ; and by striking or investigational device each place it appears (other than the second such place in paragraph (3)(A)) of subsection (c)) and inserting , investigational device, or investigational in vitro clinical test ; in subsection (b)(4) by striking or 520(g) and inserting , 520(g), or 587S each place it appears; in subsection (c)— by amending the subsection heading to read: ; Treatment Investigational New Drug Applications, Treatment Investigational Device Exemptions, and Treatment Investigational in Vitro Clinical Test Exemptions .— in paragraph (3)(A), by striking or investigational device exemption in effect under section 520(g) and inserting , investigational device exemption in effect under section 520(g), or investigational in vitro clinical test exemption under section 587S ; by striking or treatment investigational device exemption each place it appears and inserting , treatment investigational device exemption, or treatment investigational in vitro clinical test exemption ; in paragraph (5), by striking or 520(g) and inserting , 520(g), or 587S ; and in the matter following paragraph

(7)by striking or 520(g) each place it appears and inserting , 520(g) or 587S ; and by amending subsection

(e)to read as follows: In this section, the terms investigational drug , investigational device , investigational in vitro clinical test , treatment investigational new drug application , treatment investigational device exemption , and treatment investigational in vitro clinical test exemption shall have the meanings given the terms in regulations prescribed by the Secretary. . Section 569A(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8a(b)) is amended by inserting an in vitro clinical test, as defined in subsection

(ss)of such section, before or a biological product . The heading of subsection

(a)of section 569C of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–8c ) is amended by striking Drugs and Devices and inserting Drugs, Devices, and In Vitro Clinical Tests . Section 701(h)(1)(C)(ii) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 371(h)(1)(C)(ii) ) is amended by inserting and in vitro clinical tests after devices . Section 703 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 373 ) is amended— by inserting in vitro clinical tests after devices each place such term appears; and by inserting in vitro clinical test after device each place such term appears. Section 704 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374 ) (other than subsection (g)) is amended— by striking drugs or devices each place it appears and inserting drugs, devices, or in vitro clinical tests ; in subsection (a)(1), in the fourth sentence, by striking or chapter IX and inserting section 587S, section 587M, section 587N, or chapter IX ; after making the amendments in paragraphs

(1)and (2), by inserting in vitro clinical tests, after devices, each place it appears; in subsection (a)(2)(B)— by inserting or in vitro clinical tests after prescribe or use devices ; and by inserting or in vitro clinical tests after process devices ; by inserting in vitro clinical test, after device, each place it appears; in subsection (e), by inserting , or section 587M, 587N, or 587S, after section 519 or 520(g) ; in subsection (f)(3)— in subparagraph (A), by striking or at the end; in subparagraph (B), by striking the period at the end and inserting ; or ; and after subparagraph (B), by inserting the following: is accredited under section 587Q. ; and by adding at the end the following: For purposes of this section, the term establishment includes a laboratory performing an in vitro clinical test. . Section 705(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 375(b) ) is amended by inserting in vitro clinical tests, after devices, . Section 709 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379a ) is amended by inserting in vitro clinical test, after device, . Section 721(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379e(a) ) is amended— in the matter preceding paragraph (1), by inserting or in vitro clinical tests after or devices ; and in the flush text following paragraph (2)— by inserting or an in vitro clinical test after a device ; and by inserting or in vitro clinical tests after devices . Section 801 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 381 ) is amended— in subsection (a)— by inserting in vitro clinical tests, after devices, each place it appears; and by inserting in the case of an in vitro clinical test, the test does not conform to the applicable requirements of section 587K, or after requirements of section 520(f), or ; in subsection (d)(3)— in subparagraph (A)— in the matter preceding clause (i), by inserting and no component of an in vitro clinical test or other article of in vitro clinical test that requires further processing, after health-related purposes ; in clause (i), by striking drug or device and inserting drug, device, or in vitro clinical test ; and in clause (i)(I), by inserting in vitro clinical test, after device, ; and in subparagraph (B), by inserting in vitro clinical test, after device, ; in subsection (e)(1), by inserting in vitro clinical test, after device, ; and in subsection (o)— by inserting or in vitro clinical test after device ; and by inserting section 587J of each foreign establishment after section 510(i) of each establishment . Section 803 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 383 ) is amended— in subsection (b)— in the matter preceding paragraph (1), by inserting and in vitro clinical tests after devices ; and in paragraph (1), by inserting quality requirements established under section 587K; and at the end; and in subsection (c)— in paragraph (2), by inserting in vitro clinical tests, after devices, ; and in paragraph (4), by inserting or in vitro clinical tests after devices . Section 809(a)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 384e(a)(1) ) is amended by inserting , or of foreign establishments registered under section 587J after 510(h) . Section 1003(b)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 393(b)(2) ) is amended— in subparagraph (D), by striking and at the end; in subparagraph (E), by striking the semicolon at the end and inserting ; and ; and by adding at the end the following: in vitro clinical tests are analytically and clinically valid; . Section 1011(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 399b(b) ) is amended— in paragraph (1), by inserting in vitro clinical tests, after devices, ; and in paragraph (4), by striking and device manufacturers and inserting device manufacturers, and in vitro clinical test developers, . Title III of the Public Health Service Act is amended— in section 319F–1(a)(2)(A) (42 U.S.C. 247d–6a(a)(2)(A))— in the matter preceding clause (i)— by striking or device and inserting device ; and by inserting or an in vitro clinical tests (as that term is defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act ( after 21 U.S.C. 321(ss) )), Act ( ; and 21 U.S.C. 321(h) )), in each of clauses

(ii)and (iii), by striking or device and inserting device, or in vitro clinical test ; in section 319F–2(c)(1)(B) (42 U.S.C. 247d–6b(c)(1)(B))— by striking or device and inserting device ; and by inserting , or an in vitro clinical test (as that term is defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act ( after 21 U.S.C. 321(ss) )) Act ( ; and 21 U.S.C. 321(h) )), in section 319F–3(i)(7) (42 U.S.C. 247d–6d(i)(7))— in the matter preceding subparagraph (A)— by striking or device and inserting device ; and by inserting or an in vitro clinical tests (as that term is defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act ( after 21 U.S.C. 321(ss) )), Act ( ; 21 U.S.C. 321(h) ) in subparagraph (A)— by moving the margin of clause

(iii)2 ems to the left; and in clause (iii), by striking or device and inserting device, or in vitro clinical test ; and in subparagraph (B)— in clause (i), by inserting or the subject of a technology certification order after approved or cleared ; and in clause (ii), by striking or 520(g) and inserting , 520(g), or 587S .

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