ENCOURAGING PEDIATRIC MEDICAL DEVICE RESEARCH.

SEC. 304. ENCOURAGING PEDIATRIC MEDICAL DEVICE RESEARCH.(a) Contact Point for Available Funding.—Section 402(b) of the Public Health Service Act (42 U.S.C. 282(b)) is amended—(1) in paragraph (21), by striking “and” after the semicolon at the end;(2) in paragraph (22), by striking the period at the end and inserting “; and”; and(3) by inserting after paragraph (22) the following:“(23) shall designate a contact point or office to help innovators and physicians identify sources of funding available for pediatric medical device development.”.(b) Plan for Pediatric Medical Device Research.—(1) In general.—Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, the Director of the National Institutes of Health, and the Director of the Agency for Healthcare Research and Quality, shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a plan for expanding pediatric medical device research and development. In developing such plan, the Secretary of Health and Human Services shall consult with individuals and organizations with appropriate expertise in pediatric medical devices.(2) Contents.—The plan under paragraph (1) shall include—(A) the current status of federally funded pediatric medical device research;(B) any gaps in such research, which may include a survey of pediatric medical providers regarding unmet pediatric medical device needs, as needed; and(C) a research agenda for improving pediatric medical device development and Food and Drug Administration clearance or approval of pediatric medical devices, and for evaluating the short- and long-term safety and effectiveness of pediatric medical devices.