Page:United States Statutes at Large Volume 90 Part 1.djvu/624

 90 STAT. 574

21 USC 357.

Ante, p. 546.

Ante, p. 552.

PUBLIC LAW 94-295—MAY 28, 1976 hundred and eighty days after the enactment date and ending eighteen months aiter such date, restrict the use of the device to investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of such device, and to investigational use in accordance with the requirements applicable under regulations under subsection (g) of this section to investigational use of devices granted an exemption under such subsection. If the requirements under subsection (g) of this section are made applicable to the investigational use of such a device, they shall be made applicable in such a manner that the device shall be made reasonably available to physicians meeting appropriate qualifications prescribed by the Secretary. "(4) Any device intended for human use which on the enactment date was subject to the requirements of section 507 shall be subject to such requirements as follows: "(A) In the case of such a device which is classified into class I, such requirements shall apply to such device until the effective date of the regulation classifying the device into such class. "(B) In the case of such a device which is classified into class II, such requirements shall apply to such device until the effective date of a performance standard applicable to the device under section 514. "(C) In the case of such a device which is classified into class III, such requirements shall apply to such device until the date on which the device is required to have in effect an approved application under section 515. "STATE AND LOCAL REQUIREMENTS RESPECTING DEVICES

"General Rule 21 USC 360k.

"SEC. 521. (a^ Except as provided in subsection (b), no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement— "(1) which is different from, or in addition to, any requirement applicable under this Act to the device, and "(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this Act. "Exempt Requirements

Regulation. Notice and hearing.

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"(b) Upon application of a State or a political subdivision thereof, the Secretary may, by regulation promulgated after notice and opportunity for an oral hearing, exempt from subsection (a), under such conditions as may be prescribed in such regulation, a requirement of such State or political subdivision applicable to a device intended for human use if— "(1) the requirement is more stringent than a requirement under this Act which would be applicable to the device if an exemption were not in effect under this subsection; or " (2) the requirement— " ^ A) is required by compelling local conditions, and " (B) compliance with the requirement would not cause the device to be m violation of any applicable requirement under this Act.".

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