Sec. 608. RECLASSIFICATION PROCEDURES
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## SEC. 608 RECLASSIFICATION PROCEDURES ###
(a)Classification Changes ####
(1)In general Section 513(e)(1) (21 U.S.C. 360c(e)(1)) is amended to read as follows: > > ### “(e) > > > ####
(1)> > > #####
(A)> > > ######
(i)> > Based on new information respecting a device, the Secretary may, upon the initiative of the Secretary or upon petition of an interested person, change the classification of such device, and revoke, on account of the change in classification, any regulation or requirement in effect under section 514 or 515 with respect to such device, by administrative order published in the Federal Register following publication of a proposed reclassification order in the Federal Register, a meeting of a device classification panel described in subsection (b), and consideration of comments to a public docket, notwithstanding subchapter II of chapter 5 of title 5, United States Code. The proposed reclassification order published in the Federal Register shall set forth the proposed reclassification, and a substantive summary of the valid scientific evidence concerning the proposed reclassification, including— > > > ###### “(I) > > the public health benefit of the use of the device, and the nature and, if known, incidence of the risk of the device; > > > ###### “(II) > > in the case of a reclassification from class II to class III, why general controls pursuant to subsection (a)(1)(A) and special controls pursuant to subsection (a)(1)(B) together are not sufficient to provide a reasonable assurance of safety and effectiveness for such device; and > > > ###### “(III) > > in the case of reclassification from class III to class II, why general controls pursuant to subsection (a)(1)(A) and special controls pursuant to subsection (a)(1)(B) together are sufficient to provide a reasonable assurance of safety and effectiveness for such device. > > > ###### “(ii) > > An order under this subsection changing the classification of a device from class III to class II may provide that such classification shall not take effect until the effective date of a performance standard established under section 514 for such device. > > > ##### “(B) > > Authority to issue such administrative order shall not be delegated below the Director of the Center for Devices and Radiological Health, acting in consultation with the Commissioner.” > . ####
(2)Technical and conforming amendments #####
(A)Section 513(e)(2) (21 U.S.C. 360c(e)(2)) is amended by striking “regulation promulgated” and inserting “an order issued”. #####
(B)Section 514(a)(1) (21 U.S.C. 360d(a)(1)) is amended by striking “under a regulation under section 513(e) but such regulation” and inserting “under an administrative order under section 513(e) (or a regulation promulgated under such section prior to the date of enactment of the Food and Drug Administration Safety and Innovation Act) but such order (or regulation)”. #####
(C)Section 517(a)(1) (21 U.S.C. 360g(a)(1)) is amended by striking “or changing the classification of a device to class I” and inserting “, an administrative order changing the classification of a device to class I,”. ####
(3)Devices reclassified prior to the date of enactment of this act **[**[21 U.S.C. 360c note](/us/usc/t21/s360c)**]** #####
(A)In general The amendments made by this subsection shall have no effect on a regulation promulgated with respect to the classification of a device under section 513(e) of the Federal Food, Drug, and Cosmetic Act prior to the date of enactment of this Act. #####
(B)Applicability of other provisions In the case of a device reclassified under section 513(e) of the Federal Food, Drug, and Cosmetic Act by regulation prior to the date of enactment of this Act, section 517(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g(a)(1)) shall apply to such regulation promulgated under section 513(e) of such Act with respect to such device in the same manner such section 517(a)(1) applies to an administrative order issued with respect to a device reclassified after the date of enactment of this Act. ###
(b)Devices Marketed Before May 28, 1976 ####
(1)Premarket approval Section 515 (21 U.S.C. 360e) is amended— #####
(A)in subsection (a), by striking “regulation promulgated under subsection (b)” and inserting “an order issued under subsection
(b)(or a regulation promulgated under such subsection prior to the date of enactment of the Food and Drug Administration Safety and Innovation Act)”; #####
(B)in subsection (b)— ######
(i)in paragraph (1)— ######
(I)in the heading, by striking “Regulation” and inserting “Order”; and ######
(II)in the matter following subparagraph (B)— ######
(aa)by striking “by regulation, promulgated in accordance with this subsection” and inserting “by administrative order following publication of a proposed order in the Federal Register, a meeting of a device classification panel described in section 513(b), and consideration of comments from all affected stakeholders, including patients, payors, and providers, notwithstanding subchapter II of chapter 5 of title 5, United States Code”; and ######
(bb)by adding at the end the following: “Authority to issue such administrative order shall not be delegated below the Director of the Center for Devices and Radiological Health, acting in consultation with the Commissioner.”; ######
(ii)in paragraph (2)— ######
(I)by striking subparagraph (B); and ######
(II)in subparagraph (A)— ######
(aa)by striking “(2)(A) A proceeding for the promulgation of a regulation under paragraph
(1)respecting a device shall be initiated by the publication in the Federal Register of a notice of proposed rulemaking. Such notice shall contain—” and inserting “(2) A proposed order required under paragraph
(1)shall contain—”; ######
(bb)by redesignating clauses
(i)through
(iv)as subparagraphs
(A)through (D), respectively; ######
(cc)in subparagraph (A), as so redesignated, by striking “regulation” and inserting “order”; and ######
(dd)in subparagraph (C), as so redesignated, by striking “regulation” and inserting “order”; ######
(iii)in paragraph (3)— ######
(I)by striking “proposed regulation” each place such term appears and inserting “proposed order”; ######
(II)by striking “paragraph
(2)and after” and inserting “paragraph (2),”; ######
(III)by inserting “and a meeting of a device classification panel described in section 513(b),” after “such proposed regulation and findings,”; ######
(IV)by striking “(A) promulgate such regulation” and inserting “(A) issue an administrative order under paragraph (1)”; ######
(V)by striking “paragraph (2)(A)(ii)” and inserting “paragraph (2)(B)”; and ######
(VI)by striking “promulgation of the regulation” and inserting “issuance of the administrative order”; and ######
(iv)by striking paragraph (4); and #####
(C)in subsection (i)— ######
(i)in paragraph (2)— ######
(I)in the matter preceding subparagraph (A)— ######
(aa)by striking “December 1, 1995” and inserting “the date that is 2 years after the date of enactment of the Food and Drug Administration Safety and Innovation Act”; and ######
(bb)by striking “publish a regulation in the Federal Register” and inserting “issue an administrative order following publication of a proposed order in the Federal Register, a meeting of a device classification panel described in section 513(b), and consideration of comments from all affected stakeholders, including patients, payors, and providers, notwithstanding subchapter II of chapter 5 of title 5, United States Code,”; ######
(II)in subparagraph (B), by striking “final regulation has been promulgated under section 515(b)” and inserting “administrative order has been issued under subsection
(b)(or no regulation has been promulgated under such subsection prior to the date of enactment of the Food and Drug Administration Safety and Innovation Act)”; ######
(III)in the matter following subparagraph (B), by striking “regulation requires” and inserting “administrative order issued under this paragraph requires”; and ######
(IV)by striking the third and fourth sentences; and ######
(ii)in paragraph (3)— ######
(I)by striking “regulation requiring” each place such term appears and inserting “order requiring”; and ######
(II)by striking “promulgation of a section 515(b) regulation” and inserting “issuance of an administrative order under subsection (b)”. ####
(2)Technical and conforming amendments Section 501(f) (21 U.S.C. 351(f)) is amended— #####
(A)in subparagraph (1)(A)— ######
(i)in subclause (i), by striking “a regulation promulgated” and inserting “an order issued”; and ######
(ii)in subclause (ii), by striking “promulgation of such regulation” and inserting “issuance of such order”; #####
(B)in subparagraph (2)(B)— ######
(i)by striking “a regulation promulgated” and inserting “an order issued”; and ######
(ii)by striking “promulgation of such regulation” and inserting “issuance of such order”; and #####
(C)by adding at the end the following: > > #### “(3) > > In the case of a device with respect to which a regulation was promulgated under section 515(b) prior to the date of enactment of the Food and Drug Administration Safety and Innovation Act, a reference in this subsection to an order issued under section 515(b) shall be deemed to include such regulation.” > . ####
(3)Approval by regulation prior to the date of enactment of this act **[**[21 U.S.C. 351 note](/us/usc/t21/s351)**]** The amendments made by this subsection shall have no effect on a regulation that was promulgated prior to the date of enactment of this Act requiring that a device have an approval under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) of an application for premarket approval. ###
(c)Reporting **[**[21 U.S.C. 360c-1](/us/usc/t21/s360c-1)**]** The Secretary of Health and Human Services shall annually post on the Internet Web site of the Food and Drug Administration— ####
(1)the number and type of class I and class II devices reclassified as class II or class III in the previous calendar year under section 513(e)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(e)(1)); ####
(2)the number and type of class II and class III devices reclassified as class I or class II in the previous calendar year under such section 513(e)(1); and ####
(3)the number and type of devices reclassified in the previous calendar year under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e).
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Sec. 608
RECLASSIFICATION PROCEDURES
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