Sec. 4. Enforcement and other provisions

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Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ) is amended— in paragraphs (a), (b), (c), (g), (k), (q), (r), and (y), by inserting in vitro clinical test, after device, each place it appears; in paragraph

(y)by inserting or 587P after section 523 each place it appears; and by adding at the end, the following: The introduction or delivery for introduction into interstate commerce of an in vitro clinical test in violation of section 587B(a). The false, fraudulent, or deceptive claiming for an in vitro clinical test of an exemption from the premarket review required under section 587B. When claiming an exemption under section 587A from the premarket review required under section 587B, the failure to maintain complete and accurate documentation for the exemption as required under section 587A or the failure to provide labeling required under section 587A. With respect to an in vitro clinical test, the submission of any report that is required by or under this Act that is false or misleading in any material respect. The making of a false, fraudulent, or materially deceptive analytical or clinical claim for an in vitro clinical test— in any application, report, or notification submitted to the Secretary under this Act; or in the labeling or advertising of an in vitro clinical test. The failure to comply with a condition of approval, performance standard, mitigating measure, or restriction established in an order approving an application or supplement under section 587B; the failure to perform a risk analysis required by section 587B; the failure to submit an annual report required under section 587B(k); or the failure to complete postmarket studies required under section 587V. The marketing of an in vitro clinical test in violation of— an order issued by the Secretary under section 587A; or any requirement under section 587A. With respect to technology certification under section 587D, the refusal to permit, or unreasonable delay in permitting, an inspection authorized under section 587D(f)(3)(G); the failure to comply with applicable requirements to submit an application or report under section 587D(e); or the failure to comply with applicable maintenance requirements under section 587D(h). The failure to comply with an applicable mitigating measure established under section 587E or to maintain the documentation required under section 587E(b); or the failure to comply with a performance standard established under section 587Q. The failure to register in accordance with section 587I, the failure to provide information required under section 587I(b), or the failure to maintain or submit information required under section 587I(c). The failure to submit a report required under section 587L or 587M; the failure to comply with a restriction imposed under section 587N; or the failure to comply with labeling and advertising requirements under section 587N(b). The failure to comply with the requirements of section 587P (relating to accredited persons). The failure to comply with any requirement prescribed or established under section 587R; the failure to furnish any notification, information, material, or report required under section 587R; or the failure to comply with an order issued under section 587R. . Section 303(f)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 333(f)(1) ) is amended— in subparagraph (A), by inserting or in vitro clinical tests after devices ; and in subparagraph (B)(i)— by inserting , or 587J or 587L, after 520(f) ; and by inserting , or who violates section 587M(b) with respect to a correction report after risk to public health . Section 304 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 334 ) is amended— in subsection (a)(2)— by striking and before

(E)Any ; and by inserting , and

(F)Any adulterated or misbranded in vitro clinical test after tobacco product ; 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 under section 301(gg), 301(fff)(2), 301(fff)(5), or 301(fff)(8), the Secretary shall debar such person from being accredited under section 587P 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 517(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360g(a) ) is amended— in paragraph (8), by striking or at the end; in paragraph (9), by inserting or after the comma at the end; and before the matter that follows paragraph (9), by inserting the following: an order issued pursuant to section 587B, 587D, 587R, or 587S, . 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)) and inserting , investigational device, or investigational in vitro clinical test ; in subsection (b)(4) by striking or 520(g) and inserting , 520(g), or 587R 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 587R ; 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 ; and in the matter following paragraph

(7)by striking or 520(g) each place it appears and inserting , 520(g) or 587R ; 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 and inserting Drugs and Devices . 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 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 third sentence, by striking or chapter IX and inserting section 587R or chapter IX ; 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; after making the amendments in paragraphs

(1)and (2), by inserting in vitro clinical tests, after devices, each place it appears; in subsection (e), by inserting , or section 587L, 587M, or 587R, after section 519 or 520(g) ; and 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 587P. . 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 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 587J, 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, ; and in subsection (e)(1), by inserting in vitro clinical test, after device, . 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 587J; 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 section 587I 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 PHSA is amended— in section 319F–2(c)(1)(B) (42 U.S.C. 247d–6b(c)(1)(B)) is amended— 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 ( ; 21 U.S.C. 321(h) )) in section 319F–1(a)(2) (42 U.S.C. 247d–6a(a)(2)), by inserting an in vitro clinical tests (as that term is defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act ( before 21 U.S.C. 321(ss) )), or device ; and in section 319F–3(i)(7) (42 U.S.C. 247d–6d(i)(7)), by inserting an in vitro clinical tests (as that term is defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act ( before 21 U.S.C. 321(ss) )), or device .

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