title: Encouraging research and development of pediatric medical devices through legislative and regulatory action: the Pediatric Medical Device Safety and Improvement Act of 2007 in context.
abstract: In September 2007, Congress passed the Food and Drug Administration Amendments Act of 2007 (FDAAA). Title III of the FDAAA, the Pediatric Medical Safety and Improvement Act (Title III), created new incentives, mandates, Food and Drug Administration (FDA) authority and funding with the aim of increasing the availability of devices for pediatric populations while assuring the safety and effectiveness of those devices. This article describes the complex problem Title III addresses and situates Title III within the context of the regulatory scheme previously in place, particularly in relation to the one in place to address the parallel problem for pediatric drugs, and the concerns and policy recommendations of diverse stakeholders voiced leading up to Title III.
authors.affiliation: Office of the Chief Counsel, Office of the Commissioner, Food and Drug Administration, Rockville, MD, USA.
authors.forename: Ester W B
authors.initials: EW
authors.lastname: Bleicher
mesh_terms: D035843:Biomedical Research / Q000191:economics / Q000331:legislation & jurisprudence*; D002648:Child; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards; D003142:Communication; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004864:Equipment and Supplies; D032984:Ethics, Research; D033161:Government Regulation / Q000266:history; D019981:Health Care Sector; D006301:Health Services Needs and Demand; D049673:History, 20th Century; D006801:Humans; D007349:Insurance, Health, Reimbursement; D007880:Legislation, Drug; D007883:Legislation, Medical; D015969:National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division; D009316:National Institutes of Health (U.S.); D056687:Off-Label Use / Q000331:legislation & jurisprudence*; D009965:Orphan Drug Production / Q000331:legislation & jurisprudence; D010372:Pediatrics / Q000295:instrumentation* / Q000331:legislation & jurisprudence; D016032:Randomized Controlled Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards; D012106:Research / Q000191:economics / Q000331:legislation & jurisprudence*; D014481:United States; D016270:United States Agency for Healthcare Research and Quality; D014486:United States Food and Drug Administration