title: Physician modification of legally marketed medical devices: regulatory implications under the federal Food, Drug, and Cosmetic Act.
authors.affiliation: Massachusetts General Hospital, Boston, MA, USA.
authors.forename: J J
authors.initials: JJ
authors.lastname: Smith
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence; D004867:Equipment Design / Q000145:classification / Q000592:standards*; D006801:Humans; D008389:Marketing of Health Services / Q000331:legislation & jurisprudence*; D010820:Physicians / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration