title: Medical devices and health--creating a new regulatory framework for moderate-risk devices.
authors.affiliation: University of Florida, Gainesville, USA.
authors.forename: David R
authors.initials: DR
authors.lastname: Challoner
authors.forename: William W
authors.initials: WW
authors.lastname: Vodra
mesh_terms: D026683:Advisory Committees; D018795:Device Approval / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D006801:Humans; D015969:National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division; D012306:Risk; D014481:United States; D014486:United States Food and Drug Administration