title: Reporting requirements under the Safe Medical Devices Act.
authors.affiliation: Nelson Mullins Riley & Scarborough, Columbia, SC, USA.
authors.forename: A V
authors.initials: AV
authors.lastname: Harris
authors.forename: S E
authors.initials: SE
authors.lastname: Ziel
mesh_terms: D004554:Electric Countershock / Q000009:adverse effects / Q000295:instrumentation; D004868:Equipment Failure; D004864:Equipment and Supplies / Q000009:adverse effects; D006268:Health Facilities / Q000331:legislation & jurisprudence*; D058016:Health Facility Administration; D006801:Humans; D007878:Legislation as Topic; D013527:Perioperative Nursing; D012308:Risk Management / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*