Page:United States Statutes at Large Volume 104 Part 6.djvu/129

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publication. PUBLIC LAW 101-629—NOV. 28, 1990 104 STAT. 4519 SEC. 6. ESTABLISHMENT OF PERFORMANCE STANDARDS. (a) PROCEDURE.— Section 514 (21 U.S.C. 360d) is amended— (1) in subsection (a), by amending the first sentence to read as follows: "The special controls required by section 513(a)(l)(B) shall include performance standards for a class II device if the Secretary determines that a performance standard is necessary to provide reasonable assurance of the safety and effectiveness of the device.", (2) by striking out subsections (b) through (f), (3) by redesignating subsection (g) as subsection (b), (4) in subsection (b) (as redesignated), by amending paragraphs (1) and (2) to read as follows: "(I)(A) The Secretary shall publish in the Federal Register a ^^TM^ notice of proposed rulemaking for the establishment, amendment, or Jj„ revocation of any performance standard for a device. "(B) A notice of proposed rulemaking for the establishment or amendment of a performance standard for a device shall— "(i) set forth a finding with supporting justification that the performance standard is appropriate and necessary to provide reasonable assurance of the safety and effectiveness of the device, "(ii) set forth proposed findings with respect to the risk of illness or injury that the performance standard is intended to reduce or eliminate, "(iii) invite interested persons to submit to the Secretary, within 30 days of the publication of the notice, requests for changes in the classification of the device pursuant to section 513(e) based on new information relevant to the classification, and "(iv) invite interested persons to submit an existing performance standard for the device, including a draft or proposed performance standard, for consideration by the Secretary. "(C) A notice of proposed rulemaking for the revocation of a performance standard shall set forth a finding with supporting justification that the performance standard is no longer necessary to provide reasonable assurance of the safety and effectiveness of a device. "(D) The Secretary shall provide for a comment period of not less than 60 days. "(2) If, after publication of a notice in accordance with paragraph (1), the Secretary receives a request for a change in the classification of the device, the Secretary shall, within 60 days of the publication of the notice, after consultation with the appropriate panel under section 513, either deny the request or give notice of an intent to initiate such change under section 513(e).". (b) CONFORMING AMENDMENTS. — (1) Section 514(b) (as redesignated by subsection (a)(3)) is amended— (A) in paragraph (3)(A), by striking out "paragraph (2)" and inserting in lieu thereof "paragraph (1)", and (B) in paragraph (4)(A), by striking out "paragraphs (2) and (3)(B)" and inserting in lieu thereof "paragraphs (1), (2), and (3)(B)". (2) Section 520(i) (21 U.S.C. 360j(i)) is amended by striking out "514(g)(5)(B)" and inserting in lieu thereof "514(b)(5)(B)". 39-194O-91-5:QL3Part6