The Food and Drug Administration has for the first time recommended safety test requirements (PDF) for cardiac defibrillators following a growing number of recalls of the emergency medical devices in recent years.
FDA proposes tighter rules for defibrillators
The agency's proposal would require external defibrillator manufacturers to submit additional data and submit to manufacturing inspections before launching a new product.
The tighter regulation, according to FDA staff, is needed because of extensive design and manufacturing flaws among the devices, which are widely available for emergency use by the general public. The proposed changes, which will be considered by the Circulatory System Devices Panel of the Medical Devices Advisory Committee, would not apply to internal defibrillators, which are pacemaker-like devices given to patients with heart problems.
The panel is scheduled to review the recommendation Jan. 25-26 and issue a nonbinding recommendation to the agency.
The proposed regulatory review would move well beyond current FDA oversight of the devices, which subjects them to inspection only if regulators have cause to suspect a problem. Seven manufacturers argued to the FDA that the higher standard is not needed because they already utilize post-market surveillance, among other safety measures.
FDA officials noted those measures failed to prevent manufacturing problems that have resulted in 17 device recalls in 2009.
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