title: The Food and Drug Administration and atrial defibrillation devices.
abstract: BACKGROUND
  Atrial fibrillation is a common arrhythmia. It leads to significant morbidity and mortality, primarily from the increased incidence of stroke. The implantable atrial defibrillator, a new therapeutic option for the management of atrial fibrillation, is currently undergoing Food and Drug Administration (FDA) scrutiny for approval to market in the United States.
  
  
  METHODS
  A review of the basic epidemiology of atrial fibrillation, as well as the current status of accepted treatment options in light of the development of the implantable atrial defibrillator, was conducted. A literature search using the terms atrial fibrillation, implantable defibrillator, Food and Drug Administration, medical devices, and medical device regulatory law was conducted using the MEDLINE and Current Contents databases.
  
  
  RESULTS
  Currently, there is no consensus on the optimal treatment of atrial fibrillation. Despite the lack of definitive studies showing overall benefit associated with maintaining sinus rhythm in patients in atrial fibrillation, the implantable atrial defibrillator may soon reach the general market. We examine the FDA process for the evaluation of this new medical device and discuss implications for the patient, physician, industry, and health insurers.
  
  
  CONCLUSIONS
  Current FDA approval processes for new devices are a compromise between (a) the needs for expediency and encouraging innovation by the medical device industry and (b) the need to ensure that new devices will contribute to improved patient outcomes. We suggest alternative FDA-approval processes that address these issues.
authors.affiliation: Northwest Health Services Research and Development Field Program, VA Puget Sound Health Care System, Seattle, WA, USA.
authors.forename: L
authors.initials: L
authors.lastname: Chen
authors.forename: A T
authors.initials: AT
authors.lastname: Keane
authors.forename: N R
authors.initials: NR
authors.lastname: Every
mesh_terms: D001281:Atrial Fibrillation / Q000628:therapy*; D002986:Clinical Trials as Topic; D017147:Defibrillators, Implantable / Q000592:standards*; D018795:Device Approval / Q000331:legislation & jurisprudence / Q000592:standards*; D004869:Equipment Safety; D006801:Humans; D016247:Information Storage and Retrieval; D013673:Technology Assessment, Biomedical / Q000379:methods*; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration