Sec. 502. PEDIATRIC DEVICES
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## SEC. 502 PEDIATRIC DEVICES ###
(a)Pediatric Use of Devices Section 515A(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e-1(a)(3)) is amended— ####
(1)by redesignating subparagraphs
(B)through
(D)as subparagraphs
(D)through (F), respectively; ####
(2)by inserting after subparagraph
(A)the following: > > ##### “(B) > > any information, based on a review of data available to the Secretary, regarding devices used in pediatric patients but not labeled for such use for which the Secretary determines that approved pediatric labeling could confer a benefit to pediatric patients; > > > ##### “(C) > > the number of pediatric devices that receive a humanitarian use exemption under section 520(m);” > ; ####
(3)in subparagraph (E), as so redesignated, by striking “; and” and inserting “;”; ####
(4)in subparagraph
(F)(as so redesignated), by striking “(B), and (C).” and inserting “(C), (D), and (E);”; and ####
(5)by adding at the end the following: > > ##### “(G) > > the number of devices for which the Secretary relied on data with respect to adults to support a determination of a reasonable assurance of safety and effectiveness in pediatric patients; and > > > ##### “(H) > > the number of devices for which the Secretary relied on data from one pediatric subpopulation to support a determination of a reasonable assurance of safety and effectiveness in another pediatric subpopulation. > > For the items described in this paragraph, such report shall disaggregate the number of devices by pediatric subpopulation.” > . ###
(b)Humanitarian Device Exemption Section 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) is amended— ####
(1)in paragraph (4)— #####
(A)in subparagraph (B), by inserting “or an appropriate local committee” after “review committee” each place such term appears; and #####
(B)in the matter following subparagraph (B), by inserting “or an appropriate local committee” after “review committee” each place such term appears; and ####
(2)in paragraph (6)(A)(iv), by striking “2017” and inserting “2022”. ###
(c)Demonstration Grants for Improving Pediatric Availability Section 305 of the Pediatric Medical Device Safety and Improvement Act of 2007 (Public Law 110-85; 42 U.S.C. 282 note)) is amended— ####
(1)in subsection (c)— #####
(A)in paragraph (4), by striking “and” at the end; #####
(B)in paragraph (5), by striking the period and inserting “; and”; and #####
(C)by adding at the end the following: > > #### “(6) > > providing regulatory consultation to device sponsors in support of the submission of an application for a pediatric device, where appropriate.” > ; and ####
(2)in subsection (e), by striking “2013 through 2017” and inserting “2018 through 2022”. ###
(d)Meeting on Pediatric Device Development ####
(1)In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall convene a public meeting on the development, approval or clearance, and labeling of pediatric medical devices. The Secretary shall invite to such meeting representatives from the medical device industry, academia, recipients of funding under section 305 of the Pediatric Medical Device Safety and Improvement Act of 2007 (Public Law 110-85; 42 U.S.C. 282 note), medical provider organizations, and organizations representing patients and consumers. ####
(2)Topics The meeting described in paragraph
(1)shall include consideration of ways to— #####
(A)improve research infrastructure and research networks to facilitate the conduct of clinical studies of devices for pediatric populations that would result in the approval or clearance, and labeling, of medical devices for such populations; #####
(B)appropriately use extrapolation under section 515A(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e-1(b)); #####
(C)enhance the appropriate use of postmarket registries and data to increase pediatric medical device labeling; #####
(D)increase Food and Drug Administration assistance to medical device manufacturers in developing devices for pediatric populations that are approved or cleared, and labeled, for their use; and #####
(E)identify current barriers to pediatric device development and incentives to address such barriers. ####
(3)Report The report submitted under section 515A(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e-1(a)(3)) with respect to the calendar year in which the meeting described in paragraph
(1)is held shall include a summary of, and responses to, recommendations raised in such meeting.
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- Pub. L. 110-85
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