FDA Issues Proposal to Improve the Quality of Automated External Defibrillators
Proposal protects access to critical medical device:
“The U.S. Food and Drug Administration today [March 22, 2013] issued a proposed order aimed at helping manufacturers improve the quality and reliability of automated external defibrillators (AEDs). The proposed order, if finalized, will require manufacturers of these life-saving devices to submit pre-market approval (PMA) applications.
“AEDs are portable, electronic medical devices that automatically re-establish normal heart rhythms with electrical stimulation when they sense potentially life-threatening cardiac arrhythmias.
“Automated external defibrillators save lives,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. “However, the agency is concerned about the number of recalls and manufacturing problems that have been associated with these devices and we’re committed to working with manufacturers to address these issues.
“The FDA will take comments on the proposed order for 90 days. If the proposed order is finalized, the FDA intends to exercise enforcement discretion for those manufacturers that notify the FDA of their intent to file a PMA in a timely manner. The FDA intends to exercise enforcement discretion for a year and a half.”
Note: Unattributed quotes that follow are from the same US FDA press release as the above. For further information, click here.