title: The evolution of substantial equivalence in FDA's premarket review of medical devices.
authors.forename: B A
authors.initials: BA
authors.lastname: Goldberger
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence; D004869:Equipment Safety / Q000266:history / Q000639:trends; D005544:Forecasting; D017408:Guidelines as Topic; D049673:History, 20th Century; D006801:Humans; D008389:Marketing of Health Services; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000592:standards