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HR5651 Greenwood, J. (R-Pa.) 10/17/02
Enrolled (finally passed both houses)
To amend the Federal Food, Drug, and Cosmetic Act to make improvements in the regulation of medical devices, and for other purposes.
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SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) SHORT TITLE.-This Act may be cited as the "Medical Device User Fee and Modernization Act of 2002".
(b) TABLE OF CONTENTS.-The table of contents for this Act is as follows:
Sec. 1. Short title; table of contents.
TITLE II-AMENDMENTS REGARDING REGULATION OF MEDICAL DEVICES
Sec. 201. Inspections by accredited persons.
Sec. 202. Third party review of premarket notification.
Sec. 203. Debarment of accredited persons.
Sec. 204. Designation and regulation of combination products.
Sec. 205. Report on certain devices.
Sec. 206. Electronic labeling.
Sec. 207. Electronic registration.
Sec. 208. Intended use.
Sec. 209. Modular review.
Sec. 210. Pediatric expertise regarding classification-panel review of premarket applications.
Sec. 211. Internet list of class II devices exempted from requirement of premarket notification.
Sec. 212. Study by Institute of Medicine of postmarket surveillance regarding pediatric populations.
Sec. 213. Guidance regarding pediatric devices.
Sec. 214. Breast implants; study by Comptroller General.
Sec. 215. Breast implants; research through National Institutes of Health.
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.