title: The FDA review criteria for assessment of antimicrobial susceptibility devices--too much or not enough regulation?
authors.affiliation: Microscan Division, Baxter Diagnostics, West Sacramento, California.
authors.forename: K M
authors.initials: KM
authors.lastname: Tomfohrde
mesh_terms: D002986:Clinical Trials as Topic; D005069:Evaluation Studies as Topic; D006801:Humans; D007221:Industry; D007883:Legislation, Medical; D008826:Microbial Sensitivity Tests / Q000295:instrumentation* / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration