title: "Substantially equivalent": the FDA, orthopedic device manufacturer, and you.
authors.affiliation: Orthopedic Consultations, Cabin John, Maryland 20818, USA.
authors.forename: James A
authors.initials: JA
authors.lastname: Shaw
mesh_terms: D006801:Humans; D007595:Joint Prosthesis / Q000145:classification / Q000592:standards*; D011358:Product Surveillance, Postmarketing; D012042:Registries; D014481:United States; D014486:United States Food and Drug Administration