title: Regulatory and legal implications of modifying FDA-approved medical devices.
authors.affiliation: Department of Radiology, Massachusetts General Hospital, Boston 02114, USA. smith.john@mgh.harvard.edu
authors.forename: J J
authors.initials: JJ
authors.lastname: Smith
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D004867:Equipment Design; D006801:Humans; D016365:Liability, Legal; D011871:Radiology / Q000295:instrumentation / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration