FDA Proposes Higher Regulatory Scrutiny for Automatic External Defibrillators

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.

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“Automated external defibrillators save lives,” said cardiologist William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, in an FDA press release. “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 said that there have been “dozens” of AED recalls by manufacturers and that it had received approximately 45,000 adverse event reports between 2005 and 2012 relating to AED failures. FDA said that “the most common issues involve the design and manufacture of the devices and inadequate control of components purchased from other suppliers.”

The FDA announcement today is part of a broader FDA initiative to reclassify some medical devices that currently don’t require a PMA application. AED manufacturers would be required to submit clinical data demonstrating the safety and efficacy of the devices under the new rule. The FDA would also gain new authority to regulate and inspect the manufacturing process of AEDs.

If the new rule becomes final FDA said it would “exercise enforcement discretion” for a year and a half to give manufacturers time to file a PMA.

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March 22nd, 2013