Page:United States Statutes at Large Volume 90 Part 1.djvu/627

 PUBLIC LAW 94-295—MAY 28, 1976

90 STAT. 577

"(ii)(I) for which an application for premarket approval or a notice of completion of a product development protocol was not filed with the Secretary within the ninety-day period beginning on the date of the promulgation of such regulation, or " ( II) for which such an application was filed and approval of the application has been denied or withdrawn, or such a notice was filed and has been declared not completed or the approval of the device under the protocol has been withdrawn; "(B)(i) which was classified under section 513(f) into class Ante, f. 54X). I l l, which under section 515(a) is required to have in effect an ^"'e» P- 552. approved application for premarket approval, and which is not exempt from section 515 under section 520(g), and '^"'^' P- ^°^"(ii) which does not have such an application in effect; or "(C) which was classified under section 520(1) into class III, which under such section is required to have in effect an approved application under section 515, and which does not have such an application in effect. "(2)(A) In the case of a device classified under section 513(f) into class III and intended solely for investigational use, paragraph (1)(B) shall not apply with respect to such device during the period ending on the ninetieth day after the date of the promulgation of the regulations prescribing the procedures and conditions required by section 520(g)(2). "(B) In the case of a device subject to a regulation promulgated under subsection (b) of section 515, paragraph (1) shall not apply • ai. with respect to such device during the period ending— "(i) on the last day of the thirtieth calendar month beginning .. -j, after the month in which the classification of the device in class III became effective under section 513, or "(ii) on the ninetieth day after the date of the promulgation of such regulation, whichever occurs later. - ';£ " (g) If it is a banned device. "(h) If it is a device and the methods used in, or the facilities or controls used for, its manufacture, packing, storage, or installation are not in conformity with applicable requirements under section 520(f) (1) or an applicable condition prescribed by an order under section 520(f)(2).. . . .' " (i) If it is a device for which an exemption has been granted under section 520(g) for investigational use and the person who was granted such exemption or any investigator who uses such device under such exemption fails to comply with a requirement prescribed by or under such section.". S Amendments to Section 502 (e)(1) Section 502 is amended by adding at the end the following new paragraphs: "(q) In the case of any restricted device distributed or offered for sale in any State, if (1) its advertising is false or misleading; in any particular, or (2) it is sold, distributed, or used in violation of regulations prescribed under section 520(e), " (r) In the case of any restricted device distributed or offered for sale in any State, unless the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that device (1) a true statement of the device's

21 USC 352. j, ,

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