FDA Proposes Higher Regulatory Scrutiny For Automatic External Defibrillators Reply

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 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.”

Click here to read the full story on Forbes.

 

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