Page:United States Statutes at Large Volume 104 Part 6.djvu/127

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PUBLIC LAW 101-629—NOV. 28, 1990 104 STAT. 4517 revising its classification, the Secretary shall publish a proposed regulation respecting the classification of a device under this subparagraph and provide an opportunity for the submission of comments on any such regulation. No regulation under this subparagraph requiring a device to remain in class III or revising its classification may take effect before the expiration of 90 days from the date of the publication in the Federal Register of the proposed regulation. "(C) The Secretary may by notice published in the Federal Register extend the period prescribed by subparagraph (B) for a device for an additional period not to exceed 1 year.". (3)(A) Notwithstanding section 520(1)(5) of the Federal Food, 21 USC 360c Drug, and Cosmetic Act, the Secretary of Health and Human "°**' Services shall not retain any daily wear soft or daily wear nonhydrophilic plastic contact lens in class III under such Act unless the Secretary finds that it meets the criteria set forth in section 513(a)(l)(C) of such Act. The finding and the grounds for Federal the finding shall be published in the Federal Register. For any Re^^r, such lens, the Secretary shall make the determination respect- ^" ing reclassification required in section 520(1)(5)(B) of such Act within 24 months of the date of the enactment of this paragraph. (B) The Secretary of Health and Human Services may by notice published in the Federal Register extend the two-year period prescribed by subparagraph (A) for a lens for an additional period not to exceed one year. (C)(i) Before classifying a lens in class II pursuant to subparagraph (A), the Secretary of Health and Human Services shall pursuant to section 513(a)(1)(B) of such Act assure that appropriate regulatory safeguards are in effect which provide reasonable assurance of the safety and effectiveness of such lens, including clinical and preclinical data if deemed necessary by the Secretary. (ii) Prior to classifying a lens in class I pursuant to subparagraph (A), the Secretary shall assure that appropriate regulatory safeguards are in effect which provide reasonable assurance of the safety and effectiveness of such lens, including clinical and preclinical data if deemed necessary by the Secretary. (D) Notwithstanding section 520(1)(5) of such Act, if the Secretary of Health and Human Services has not made the finding and published the finding required by subparagraph (A) within 36 months of the date of the enactment of this subparagraph, the Secretary shall issue an order placing the lens in class II. (E) Any person adversely affected by a final regulation under this paragraph revising the classification of a lens may challenge the revision of the classification of such lens only by filing a petition under section 513(e) for a classification change. SEC. 5. CLASSIFICATION AND RECLASSIFICATION OF DEVICES. (a) STANDARDS.— (1) Section 513(a)(l)(A)(ii) (21 U.S.C. 360c(a)(l)(A)(ii)) is amended by striking out "or to establish a performance standard" and inserting in lieu thereof "or to establish special controls". (2) Section 513(a)(l)(B) (21 U.S.C. 360c(a)(l)(B)) is amended to read as follows: