March 22nd, 2013
FDA Proposes Higher Regulatory Scrutiny for Automatic External Defibrillators
Larry Husten, PHD
Automated external defibrillators (AEDs) will have a more difficult time getting on the market if a new FDA proposal is finalized. The agency today proposed a new rule that will require AED manufacturers to submit pre-market approval (PMA) applications. “Automated external defibrillators save lives,” said cardiologist William Maisel, deputy director of science and chief scientist at […]