Page:United States Statutes at Large Volume 90 Part 1.djvu/597

 PUBLIC LAW 94-295—MAY 28, 1976 clause (ii) show that the device is in conformity with the portions of the standard for which the test or tests were required, and "(v) a provision requiring that the sale and distribution of the device be restricted but only to the extent that the i sale and distribution of a device may be restricted under a regulation under section 520(e); and "(C) shall, where appropriate, require the use and prescribe the form and content of labeling for the proper installation, maintenance, operation, and use of the device. "(4) The Secretary shall provide for periodic evaluation of performance standards established under this section to determine if such standards should be changed to reflect new medical, scientific, or other technological data. "(5) In carrying out his duties under this section, the Secretary shall, to the maximum extent practicable— "(A) use personnel, facilities, and other technical support available in other Federal agencies, "(B) consult with other Federal agencies concerned with standard-setting and other nationally or internationaly recognized standard-setting entities, and "(C) invite appropriate participation, through joint or other conferences, workshops, or other means, by informed persons representative of scientific, professional, industry, or consumer organizations who in his judgment can make a significant contribution.

90 STAT. 547

Post, p, 565. Labeling, Periodic evaluation, jj I

"Initiation of a Proceeding for a Performance Standard "(b)(1) A proceeding for the development of a performance stand- Publication in ard for a device shall be initiated by the Secretary by the publication Federal Register, in the Federal Eegister of notice of the opportunity to submit to the Secretary a request (within fifteen days of the date of the publication of the notice) for a change in the classification of the device based on new information relevant to its classification. "(2) If, after publication of a notice pursuant to paragraph (1) the Secretary receives a request for a change in the device's classification, he shall, within sixty days of the publication of such notice and after consultation with the appropriate panel under section 513, by -^"'e, p. 540. order published in the Federal Register, either deny the request for change in classification or give notice of his intent to initiate such a change under section 513(e). o>^.

"Invitation for Standards

"(c)(1) If, after the publication of a notice under subsection (b), Publication in no action is required under paragraph (2) of such subsection or the Federal Register. Secretary denies a request to change the classification of the device with respect to which such notice was published, the Secretary shall publish in the Federal Register a notice inviting any person, including any Federal agency, to— " (A) submit to the Secretary, within sixty days after the date of publication of the notice, an existing standard as a proposed performance standard for such device, or "(B) offer, within sixty days after the date of publication of the notice, to develop such a proposed standard, "(2) A notice published pursuant to paragraph (1) for an offer for the development of a proposed performance standard for a device— "(A) shall specify a period within which the standard is to be

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