Page:United States Statutes at Large Volume 90 Part 1.djvu/621

 PUBLIC LAW 94-295—MAY 28, 1976

90 STAT. 571

conditions applicable to the device under this subsection for such exemption are not met. Such an order may be issued only after opportunity for an informal hearing, except that such an order may be issued before the provision of an opportunity for an informal hearing if the Secretary determines that the continuation of testing under the exemption with respect to which the order is to be issued will result in an unreasonable risk to the public health. "Kelease of Safety and Effectiveness Information "(h)(1) The Secretary shall promulgate regulations under which a detailed summary of information respecting the safety and effectiveness of a device which information was submitted to the Secretary and which was the basis for— "(A) an order under section 515(d)(1)(A) approving an application for premarket approval for the device or denying approval of such an application or an order under section 515(e) withdrawing approval of such an application for the device, "(B) an order under section 515(f)(6)(A) revoking an approved protocol for the device, an order under section 515(f) (6)(B) declaring a protocol for the device completed or not completed, or an order under section 515(f)(7) revoking the approval of the device, or "(C) an order approving an application under subsection (g) for an exemption for the device from section 516 or an order disapproving, or withdrawing approval of, an application for an exemption under such subsection for the device, shall be made available to the public upon issuance of the order. Summaries of information made available pursuant to this paragraph respecting a device shall include information respecting any adverse effects on health of the device. "(2) The Secretary shall promulgate regulations under which each advisory committee established under section 515(g)(2)(B) shall make available to the public a detailed summary of information respecting the safety and effectiveness of a device which information was submitted to the advisory committee and which was the basis for its recommendation to the Secretary made pursuant to section 515 (s)(2)(A). A summary of information upon which such a recommendation is based shall be made available pursuant to this paragraph only after the issuance of the order with respect to which the recommendation was made and each summary shall include information respecting any adverse effect on health of the device subject to such order. "(3) Any information respecting a device which is made available pursuant to paragraph (1) or (2) of this subsection (A) may not be used to establish the safety or effectiveness of another device for purposes of this Act by any person other than the person who submitted the information so made available, and (B) shall be made available subject to subsection (c) of this section.

•; Regulations,

Ante, p. 552.

Ante, p. 560.

Regulations,

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,

"Proceedings of Advisory Panels and Committees "(i) Each panel under section 513 and each advisory committee Ante, p. 540. estaljlished under section 514(g)(5)(B) or 515(g) or under subsection Ante, p. 546. (f) of this section shall make and maintain a transcript of any proceeding of theCpanel or committee. Each such panel and committee shall d.elete from any transcript made pursuant to this subsection information which under subsection (c) of this section is to be considered confidential.

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