Page:United States Statutes at Large Volume 121.djvu/942

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[121 STAT. 921]
[121 STAT. 921]
PUBLIC LAW 110-000—MMMM. DD, 2007

PUBLIC LAW 110–85—SEPT. 27, 2007

121 STAT. 921

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(D) in paragraph (5), as so redesignated, by striking ‘‘paragraph (1) or (2)’’ each place it appears and inserting ‘‘paragraph (1), (2), or (3)’’; (E) in paragraph (6), as so redesignated, by striking ‘‘paragraph (3)(A)’’ and inserting ‘‘paragraph (5)(A)’’; and (F) in paragraph (7), as so redesignated, by striking ‘‘paragraph (4)’’ each place it appears and inserting ‘‘paragraph (6)’’. (3) NEW DRUGS AND DEVICES.— (A) INVESTIGATIONAL NEW DRUGS.—Section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) is amended in paragraph (4), by adding at the end the following: ‘‘The Secretary shall update such regulations to require inclusion in the informed consent documents and process a statement that clinical trial information for such clinical investigation has been or will be submitted for inclusion in the registry data bank pursuant to subsection (j) of section 402 of the Public Health Service Act.’’. (B) NEW DRUG APPLICATIONS.—Section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended by adding at the end the following: ‘‘(6) An application submitted under this subsection shall be accompanied by the certification required under section 402(j)(5)(B) of the Public Health Service Act. Such certification shall not be considered an element of such application.’’. (C) DEVICE REPORTS UNDER SECTION 510(k).—Section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)) is amended by adding at the end the following: ‘‘A notification submitted under this subsection that contains clinical trial data for an applicable device clinical trial (as defined in section 402(j)(1) of the Public Health Service Act) shall be accompanied by the certification required under section 402(j)(5)(B) of such Act. Such certification shall not be considered an element of such notification.’’. (D) DEVICE PREMARKET APPROVAL APPLICATION.—Section 515(c)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)(1)) is amended— (i) in subparagraph (F), by striking ‘‘; and’’ and inserting a semicolon; (ii) by redesignating subparagraph (G) as subparagraph (H); and (iii) by inserting after subparagraph (F) the following: ‘‘(G) the certification required under section 402(j)(5)(B) of the Public Health Service Act (which shall not be considered an element of such application); and’’. (E) HUMANITARIAN DEVICE EXEMPTION.—Section 520(m)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)) is amended in the first sentence in the matter following subparagraph (C), by inserting at the end before the period ‘‘and such application shall include the certification required under section 402(j)(5)(B) of the Public Health Service Act (which shall not be considered an element of such application)’’. (c) SURVEILLANCES.—Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human

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Certification.

Regulations.

21 USC 360j.

Deadline. Guidance. 42 USC 282 note.

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