Page:United States Statutes at Large Volume 116 Part 2.djvu/832

 116 STAT. 1614 PUBLIC LAW 107-250—OCT. 26, 2002 21 USC 360/ note. Deadline. 21 USC 360j note. Deadline. SEC. 210. PEDIATRIC EXPERTISE REGARDING CLASSIFICATION-PANEL REVIEW OF PREMARKET APPLICATIONS. Section 515(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)), as amended by section 302(c)(2)(A) of this Act, is amended in paragraph (3) by adding at the end the following: "Where appropriate, the Secretary shall ensure that such panel includes, or consults with, one or more pediatric experts.". SEC. 211. INTERNET LIST OF CLASS II DEVICES EXEMPTED FROM REQUIREMENT OF PREMARKET NOTIFICATION. Section 510(m)(l) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(m)(l)) is amended by adding at the end the following: "The Secretary shall publish such list on the Internet site of the Food and Drug Administration. The list so published shall be updated not later than 30 days after each revision of the list by the Secretary.". SEC. 212. STUDY BY INSTITUTE OF MEDICINE OF POSTMARKET SURVEILLANCE REGARDING PEDIATRIC POPULATIONS. (a) IN GENERAL. —The Secretary of Health and Human Services (referred to in this section as the "Secretary") shall request the Institute of Medicine to enter into an agreement with the Secretary under which such Institute conducts a study for the purpose of determining whether the system under the Federal Food, Drug, and Cosmetic Act for the postmarket surveillance of medical devices provides adequate safeguards regarding the use of devices in pediatric populations. (b) CERTAIN MATTERS. —The Secretary shall ensure that determinations made in the study under subsection (a) include determinations of— (1) whether postmarket surveillance studies of implanted medical devices are of long enough duration to evaluate the impact of growth and development for the number of years that the child will have the implant, and whether the studies are adequate to evaluate how children's active lifestyles may affect the failure rate and longevity of the implant; and (2) whether the postmarket surveillance by the Food and Drug Administration of medical devices used in pediatric populations is sufficient to provide adequate safeguards for such populations, taking into account the Secretary's monitoring of commitments made at the time of approval of medical devices, such as phase IV trials, and the Secretary's monitoring and use of adverse reaction reports, registries, and other postmarket surveillance activities. (c) REPORT TO CONGRESS.— The Secretary shall ensure that, not later than four years after the date of the enactment of this Act, a report describing the findings of the study under subsection (a) is submitted to the Congress. The report shall include any recommendations of the Secretary for administrative or legislative changes to the system of postmarket surveillance referred to in such subsection. SEC. 213. GUIDANCE REGARDING PEDIATRIC DEVICES. Not later than 270 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue guidance on the following:

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