title: Defining "least burdensome means" under the Food and Drug Administration Modernization Act of 1997.
authors.affiliation: Harvard Medical School, USA.
authors.forename: J J
authors.initials: JJ
authors.lastname: Smith
authors.forename: A M
authors.initials: AM
authors.lastname: Shyjan
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence / Q000592:standards; D017598:Efficiency, Organizational / Q000331:legislation & jurisprudence; D006801:Humans; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration