1. Short title This Act may be cited as the Pediatric Device Development Act . 2. Pediatric uses of devices Section 515A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360e–1 ) is amended— (1) in subsection (a)(3)— (A) by redesignating subparagraphs (B) through (D) as subparagraphs (D) through (F), respectively; (B) by inserting after subparagraph (A) the following: (B) an assessment of pediatric device labeling needs, based on a review of real world evidence on the off-label use of medical devices in children, drawn from data available to the Food and Drug Administration; (C) the number of devices that receive a humanitarian use exemption under section 520(m); ; (C) in subparagraph (E) (as so redesignated), by striking ; and and inserting ; ; (D) in subparagraph (F) (as so redesignated), by striking (B), and (C). and inserting (C), (D), and (E); and ; and (E) by adding at the end the following: (G) the number of devices for which extrapolation was used to support the approval of pediatric labeling of such devices. For the items described in this paragraph, such report shall disaggregate the number of devices by pediatric subpopulation. ; (2) by redesignating subsection (c) as subsection (d); and (3) by inserting after subsection (b), the following: (c) Pediatric device innovation (1) In general The Secretary shall, not later than 1 year after the date of enactment of the Pediatric Device Development Act , establish within the Center for Devices and Radiological Health a structure to— (A) provide assistance to device manufacturers, in coordination with the relevant review committees, as appropriate, that would result in the development, approval, and labeling of medical devices for children; (B) oversee an internal pediatrics team that— (i) is comprised of— (I) employees of the Food and Drug Administration with expertise in pediatrics and appropriate expertise pertaining to the relevant devices under review; and (II) other individuals designated by the Secretary