title: The FDA's humanitarian device exemption program.
authors.forename: Malvina B
authors.initials: MB
authors.lastname: Eydelman
authors.forename: Eric A
authors.initials: EA
authors.lastname: Chen
mesh_terms: D003132:Commerce / Q000331:legislation & jurisprudence; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004864:Equipment and Supplies; D033161:Government Regulation; D008389:Marketing of Health Services; D014481:United States; D014486:United States Food and Drug Administration