Sec. 613. HUMANITARIAN DEVICE EXEMPTIONS
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## SEC. 613 HUMANITARIAN DEVICE EXEMPTIONS ###
(a)In General Section 520(m) (21 U.S.C. 360j(m)) is amended— ####
(1)in paragraph (6)— #####
(A)in subparagraph (A)— ######
(i)by striking clause
(i)and inserting the following: > > ###### “(i) > > The device with respect to which the exemption is granted— > > > ###### “(I) > > is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or condition occurs; or > > > ###### “(II) > > is intended for the treatment or diagnosis of a disease or condition that does not occur in pediatric patients or that occurs in pediatric patients in such numbers that the development of the device for such patients is impossible, highly impracticable, or unsafe.” > ; and ######
(ii)by striking clause
(ii)and inserting the following: > > ###### “(ii) > > During any calendar year, the number of such devices distributed during that year under each exemption granted under this subsection does not exceed the annual distribution number for such device. In this paragraph, the term ‘annual distribution number’ means the number of such devices reasonably needed to treat, diagnose, or cure a population of 4,000 individuals in the United States. The Secretary shall determine the annual distribution number when the Secretary grants such exemption.” > ; and #####
(B)by amending subparagraph
(C)to read as follows: > > ##### “(C) > > A person may petition the Secretary to modify the annual distribution number determined by the Secretary under subparagraph (A)(ii) with respect to a device if additional information arises, and the Secretary may modify such annual distribution number.” > ; ####
(2)in paragraph (7), by striking “regarding a device” and inserting “regarding a device described in paragraph (6)(A)(i)(I)”; and ####
(3)in paragraph (8), by striking “of all devices described in paragraph (6)” and inserting “of all devices described in paragraph (6)(A)(i)(I)”. ###
(b)Applicability to Existing Devices **[**[21 U.S.C. 360j note](/us/usc/t21/s360j)**]** A sponsor of a device for which an exemption was approved under paragraph
(2)of section 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) before the date of enactment of this Act may seek a determination under subclause
(I)or
(II)of section 520(m)(6)(A)(i) (as amended by subsection (a)). If the Secretary of Health and Human Services determines that such subclause
(I)or
(II)applies with respect to a device, clauses (ii), (iii), and
(iv)of subparagraph
(A)and subparagraphs (B), (C), (D), and
(E)of paragraph
(6)of such section 520(m) shall apply to such device, and the Secretary shall determine the annual distribution number for purposes of clause
(ii)of such subparagraph
(A)when making the determination under this subsection.
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Sec. 613
HUMANITARIAN DEVICE EXEMPTIONS
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