Page:United States Statutes at Large Volume 104 Part 6.djvu/128

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104 STAT. 4518 PUBLIC LAW 101-629—NOV. 28, 1990 "(B) CLASS II, SPECIAL CONTROLS.— A device which cannot be classified as a class I device because the general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines (including guidelines for the submission of clinical data in premarket notification submissions in accordance with section 510(k)), recommendations, and other appropriate actions as the Secretary deems necessary to provide such assurance. For a device that is purported or represented to be for a use in supporting or sustaining human life, the Secretary shall examine and identify the special controls, if any, that are necessary to provide adequate assurance of safety and effectiveness and describe how such controls provide such assurance.". (3) Clause (i) of section 513(a)(1)(C) (21 U.S.C. 360c(a)(l)(C)) is amended to read as follows: "(i) it (I) cannot be classified as a class I device because insufficient information exists to determine that the application of general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device, and (II) cannot be classified as a class II device because insufficient information exists to determine that the special controls described in subparagraph (B) would provide reasonable assurance of its safety and effectiveness, and". (b) CLASSIFICATION CHANGE.—Section 513(e) (21 U.S.C. 360c(e)) is amended by redesignating clauses (1) and (2) as clauses (A) and (B), respectively, and by inserting "(1)" after "(e)" and by adding at the end the following: "(2) By regulation promulgated under paragraph (1), the Secretary may change the classification of a device from class III— "(A) to class II if the Secretary determines that special controls would provide reasonable assurance of the safety and effectiveness of the device and that general controls would not provide reasonable assurance of the safety and effectiveness of the device, or "(B) to class I if the Secretary determines that general controls would provide reasonable assurance of the safety and effectiveness of the device.". (c) F.D.A. AUTHORITY TO INITIATE RECLASSIFICATION. — (1) Section 513(f)(2)(A) (21 U.S.C 360c(f)(2)(A)) is amended by striking out "The manufacturer" and inserting in lieu thereof "The Secretary may initiate the reclassification of a device classified into class III under paragraph (1) of this subsection or ^ll6 IH£Lll.llf£LC^U.]T61* (2) Section 520(1)(2) (21 U.S.C. 360j(l)(2)) is amended by striking out "The manufacturer" and inserting in lieu thereof "The Secretary may initiate the reclassification of a device classified into class III under paragraph (1) of this subsection or the manufacturer. (3) The heading for section 513(f) (21 U.S.C. 360c(f)) is amended by inserting "and Reclassification" before "of.