AMENDMENTS TO OFFICE OF PEDIATRIC THERAPEUTICS AND PEDIATRIC ADVISORY COMMITTEE.

SEC. 306. AMENDMENTS TO OFFICE OF PEDIATRIC THERAPEUTICS AND PEDIATRIC ADVISORY COMMITTEE.(a) Office of Pediatric Therapeutics.—Section 6(b) of the Best Pharmaceuticals for Children Act (21 U.S.C. 393a(b)) is amended by inserting “, including increasing pediatric access to medical devices” after “pediatric issues”.121 STAT. 865(b) Pediatric Advisory Committee.—Section 14 of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended—(1) in subsection (a), by inserting “(including drugs and biological products) and medical devices” after “therapeutics”; and(2) in subsection (b)—(A) in paragraph (1), by inserting “(including drugs and biological products) and medical devices” after “therapeutics”; and(B) in paragraph (2)—(i) in subparagraph (A), by striking “and 505B” and inserting “505B, 510(k), 515, and 520(m)”;(ii) by striking subparagraph (B) and inserting the following:“(B) identification of research priorities related to therapeutics (including drugs and biological products) and medical devices for pediatric populations and the need for additional diagnostics and treatments for specific pediatric diseases or conditions;”; and(iii) in subparagraph (C), by inserting “(including drugs and biological products) and medical devices” after “therapeutics”.