Page:United States Statutes at Large Volume 90 Part 1.djvu/622

 90 STAT. 572

PUBLIC LAW 94-295—MAY 28, 1976 "Traceability Requirements "(j) No regulation under this Act may impose on a type or class of device requirements for the traceability of such type or class of device unless such requirements are necessary to assure the protection of the public health. "Research and Development

G>ntracts.

"(k) The Secretary may enter into contracts for research, testing, and demonstrations respecting devices and may obtain devices for research, testing, and demonstration purposes without regard to sections 3648 and 3709 of the Revised Statutes (31 U.S.C. 529, 41 U.S.C. 5). "Transitional Provisions for Devices Considered as New Drugs or Antibiotic Drugs

" (1)(1) Any device intended for human use— " (A) for which on the date of enactment of the Medical Device Amendments of 1976 (hereinafter in this subsection referred to as the 'enactment date') an approval of an application sub21 USC 355. mitted under section 505(b) was in effect; "(B) for which such an application was filed on or before the enactment date and with respect to which application no order of approval or refusing to approve had been issued on such date under subsection (c) or (d) of such section; "(C) for which on the enactment date an exemption under subsection (i) of such section was in effect; "(D) which is within a type of device described in subparagraph (A), (B),or (C) and is substantially equivalent to another device within that type; " (E) which the Secretary in a notice published in the Federal Register before the enactment date has declared to be a new drug subject to section 505; or " (F) with respect to which on the enactment date an action is 21 USC 332-334. pending in a United States court under section 302, 303, or 304 21 USC 331. for an alleged violation of a provision of section 301 which enforces a requirement of section 505 or for an alleged violation of section 505(a), is classified in class III unless the Secretary in response to a petition submitted under paragraph (2) has classified such device in class I orlL PetitioB. "(2) The manufacturer or importer of a device classified under paragraph (1) may petition the Secretary (in such form and manner as he shall prescribe) for the issuance of an order classifying the Notification. device in class I or class II. Within thirty days of the filing of such a petition, the Secretary shall notify the petitioner of any deficiencies in the petition which prevent the Secretary from making a decision Hearing. on the petition. Except as provided in paragraph (3)(D) ( i i), within one hundred and eighty days after the filing of a petition under this paragraph and after affording the petitioner an opportunity for an informal hearing, the Secretary shall, after consultation with the Ante, p. 540. appropriate panel under section 513, by order either deny the petition or order the classification, in accordance with the criteria prescribed by section 513(a)(1)(A) or 513(a)(1)(B), of the device in class I or class II.

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