Page:United States Statutes at Large Volume 90 Part 1.djvu/629

 PUBLIC LAW 94-295—MAY 28, 1976 or installation of the device do not conform to the requirements of section 520(f) ". REGISTRATION OF DEVICE

90 STAT. 579 Ante, p. 565.

MANUFACTURERS

SEC. 4. (a) Section 510 is amended as follows: (1) The section heading is amended by inserting "AND DEVICES" after "DRUGS". (2) Subsection (a)(1) is amended by inserting "or device package" after "drug package"; by inserting "or device" after "the drug"; and by inserting "or user" after "consumer". (3) Subsections (b), (c), and (d) are amended by inserting "or a device or devices" after "drugs" each time it occurs. (4) Subsection (e) is amended by adding at the end the following: "The Secretary may by regulation prescribe a uniform system for the identification of devices intended for human use and may require that persons who are required to list such devices pursuant to subsection (j) shall list such devices in accordance with such system.". (5) Subsection (g) is amended by inserting "or devices" after "drugs" each time such term occurs in paragraphs (1), (2), and (3) of such subsection. (6) Subsection (h) is amended by inserting after "704 and" the following: "every such establishment engaged in the manufacture, propagation, compounding, or processing of a drug or drugs or of a device or devices classified in class II or III". (7) The first sentence of subsection (i) is amended by inserting ", or a device or devices," after "drug or drugs"; and the second sentence of such subsection is amended by inserting "shall require such establishment to provide the information required by subsection (j) in the case of a device or devices and" immediately before "shall include" and by inserting "or devices" after "drugs". (8) Subsection (j) is amended— (A) in the matter preceding subparagraph (A) of paragraph (1), by striking out "a list of all drugs (by established name" and inserting in lieu thereof "a list of all drugs and a list of all devices and a brief statement of the basis for believing that each device included in the list is a device rather than a drug (with each drug and device in each list listed by its established name", and by striking out "drugs filed" and inserting in lieu thereof "drugs or devices filed"; (B) in paragraph (1)(A), by striking out "such list" and inserting in lieu thereof "the applicable list"; by inserting "or a device intended for human use contained in the applicable list with respect to which a performance standard has been established under section 514 or which is subject to section 515," after "512,", and by inserting "or device" after "such drug" each time it appears; (C) in paragraph (1)(B), by striking out "drug contained in such list" before clause (i) and inserting in lieu thereof "drug or device contained in an applicable list"; (D) by amending clause (i) of paragraph (1)(B) to read as follows— "(i) which drug is subject to section 503(b)(1), or which device is a restricted device, a copy of all labeling for such drug or device, a representative sampling of advertisements for such drug or device, and, upon request made by the Secretary for good cause, a copy of all advertisements for a particular drug product or device, or";

21 USC 360.

.i. Ante, pp. 546, ^^2.

21 USC 353.

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