121 STAT. 860
PUBLIC LAW 110–85—SEPT. 27, 2007
‘‘(D) the review time for each device described in subparagraphs (A), (B), and (C). ‘‘(b) DETERMINATION OF PEDIATRIC EFFECTIVENESS BASED ON SIMILAR COURSE OF DISEASE OR CONDITION OR SIMILAR EFFECT OF DEVICE ON ADULTS.— ‘‘(1) IN GENERAL.—If the course of the disease or condition and the effects of the device are sufficiently similar in adults and pediatric patients, the Secretary may conclude that adult data may be used to support a determination of a reasonable assurance of effectiveness in pediatric populations, as appropriate. ‘‘(2) EXTRAPOLATION BETWEEN SUBPOPULATIONS.—A study may not be needed in each pediatric subpopulation if data from one subpopulation can be extrapolated to another subpopulation. ‘‘(c) PEDIATRIC SUBPOPULATION.—For purposes of this section, the term ‘pediatric subpopulation’ has the meaning given the term in section 520(m)(6)(E)(ii).’’. SEC. 303. MODIFICATION TO HUMANITARIAN DEVICE EXEMPTION.
dkrause on GSDDPC44 with PUBLAW
(a) IN GENERAL.—Section 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) is amended— (1) in paragraph (3), by striking ‘‘No’’ and inserting ‘‘Except as provided in paragraph (6), no’’; (2) in paragraph (5)— (A) by inserting ‘‘, if the Secretary has reason to believe that the requirements of paragraph (6) are no longer met,’’ after ‘‘public health’’; and (B) by adding at the end the following: ‘‘If the person granted an exemption under paragraph (2) fails to demonstrate continued compliance with the requirements of this subsection, the Secretary may suspend or withdraw the exemption from the effectiveness requirements of sections 514 and 515 for a humanitarian device only after providing notice and an opportunity for an informal hearing.’’; and (3) by striking paragraph (6) and inserting after paragraph (5) the following new paragraphs: ‘‘(6)(A) Except as provided in subparagraph (D), the prohibition in paragraph (3) shall not apply with respect to a person granted an exemption under paragraph (2) if each of the following conditions apply: ‘‘(i)(I) The device with respect to which the exemption is granted 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. ‘‘(II) The device was not previously approved under this subsection for the pediatric patients or the pediatric subpopulation described in subclause (I) prior to the date of the enactment of the Pediatric Medical Device Safety and Improvement Act of 2007. ‘‘(ii) During any calendar year, the number of such devices distributed during that year does not exceed the annual distribution number specified by the Secretary when the Secretary grants such exemption. The annual distribution number shall
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