Page:United States Statutes at Large Volume 90 Part 1.djvu/630

 90 STAT. 580

21 USC 353.

Ante, pp. 546, 552.

Report.

Ante, p. 540.

21 USC 331. 21 USC 352. 21 USC 360.

21 USC 381.

PUBLIC LAW 94-295—MAY 28, 1976 (E) by amending clause (ii) of paragraph (1)(B) to read as follows: "(ii) which drug is not subject to section 503(b)(1) or which device is not a restricted device, the label and package insert for such drug or device and a representative sampling of any other labeling for such dru^ or device;"; (F) in paragraph (1)(C), by striking out "such list" and inserting "an applicable list" in lieu thereof; (G) m paragraph (1)(D), by striking out "the list" and inserting in lieu thereof "a list"; by inserting "or the particular device contained in such list is not subject to a performance standard established under section 514 or to section 515 or is not a, restricted device" after "512,"; and by inserting "or device" after "particular drug product" each place it occurs; and (H) in paragraph (2), by inserting "or device" after "drug" each time it appears and, in paragraph (2)(C), by inserting "each" before "by established name". (9) Such section is amended by adding after subsection (j) the following new subsection: "(k) Each person who is required to register under this section and who proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use shall, at least ninety days before making such introduction or deli\'ery, report to the Secretary (in such form and manner as the Secretary shall by regulation prescribe)— "(1) the class in which the device is classified under section 513 or if such person determines that the device is not classified under such section, a statement of that determination and the basis for such person's determination that the device is or is not so classified, and "(2) action taken by such person to comply with requirements under section 514 or 515 which are applicable to the device.". (b)(1) Section 301(p) is amended by striking out "510(j)," and inserting in lieu thereof "510 (j) or 510 (k),". (2) Section 502(o) is amended (A) by striking out "is a drug and" and (B) by inserting before the period a comma and the following: "if it was not included in a list required by section 510(j), if a notice or other information respecting it was not provided as required by such section or section 510(k), or if it does not bear such symbols from the uniform system for identification of devices prescribed under section 510(e) as the Secretary by regulation requires". (3) The second sentence of section 801(a) is amended by inserting "or devices" after "drugs" each time it occurs. DEVICE ESTABLISHED AND OFFICIAL NAMES

21 USC 352.

SEC. 5. (a)(1) Subparagraph (1) of section 502(e) is amended by striking out "subparagraph (2)" and inserting in lieu thereof "subparagraph (3)". (2) Subparagraph (2) of such section is redesignated as subparagraph (3) and is amended by striking out "this paragraph (e)" and inserting in lieu thereof "subparagraph (1)". (3) Such section is amended by adding after subparagraph (1) the following new subparagraph: "(2) If it is a device and it has an established name, unless its label bears, to the exclusion of any other nonproprietary name, its established name (as defined in subparagraph (4)) prominently printed in type at least half as large as that used thereon for any proprietary

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