The Food and Drug Administration's regulation of risk disclosure for implantable cardioverter defibrillators: has technology outpaced the Agency's regulatory framework?
Basile
Edward M
EM
King & Spaulding L.L.P., Washington, D.C., USA.
Lorell
Beverly H
BH
D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D017147:Defibrillators, Implantable / Q000009:adverse effects / Q000191:economics; D018795:Device Approval / Q000331:legislation & jurisprudence; D030881:Disclosure / Q000331:legislation & jurisprudence; D004868:Equipment Failure; D004869:Equipment Safety; D006801:Humans; D007221:Industry / Q000331:legislation & jurisprudence; D019221:Mandatory Reporting; D011356:Product Labeling / Q000331:legislation & jurisprudence; D011358:Product Surveillance, Postmarketing; D012306:Risk; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence