title: IRBs and Humanitarian Device Exemptions (HDEs).
authors.affiliation: The Deem Corporation, P.O. Box 44069, Omaha, NE 68144, USA.
authors.forename: D M
authors.initials: DM
authors.lastname: Maloney
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D026724:Ethical Review; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration