title: Advancing regulatory science to bring novel medical devices for use in emergency care to market: the role of the Food and Drug Administration.
abstract: The Food and Drug Administration (FDA) performs regulatory science to provide science-based medical product regulatory decisions. This article describes the types of scientific research the FDA's Center for Devices and Radiological Health performs and highlights specific projects related to medical devices for emergency medicine. In addition, this article discusses how results from regulatory science are used by the FDA to support the regulatory process as well as how the results are communicated to the public. Regulatory science supports the FDA's mission to assure safe, effective, and high-quality medical products are available to patients.
authors.affiliation: Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD.
authors.forename: Christopher G
authors.initials: CG
authors.lastname: Scully
authors.affiliation: Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD.
authors.forename: Shawn
authors.initials: S
authors.lastname: Forrest
authors.affiliation: Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD.
authors.forename: Loriano
authors.initials: L
authors.lastname: Galeotti
authors.affiliation: Office of the Center Director, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD.
authors.forename: Suzanne B
authors.initials: SB
authors.lastname: Schwartz
authors.affiliation: Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD. Electronic address: david.strauss@fda.hhs.gov.
authors.forename: David G
authors.initials: DG
authors.lastname: Strauss
mesh_terms: D035843:Biomedical Research / Q000379:methods; D004632:Emergency Medical Services / Q000379:methods; D004864:Equipment and Supplies / Q000009:adverse effects / Q000592:standards*; D033161:Government Regulation; D006801:Humans; D008991:Monitoring, Physiologic / Q000295:instrumentation; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*