The Food and Drug Administration (FDA) has recently issued a press release outlining some proposed changes to their automated external defibrillator (AED) approval process. If the proposed order is finalized, AED manufacturers will be required to submit “pre-market approval applications” for their devices.
The FDA will be accepting comments on the proposal for 90 days.
Watch our blog for details as this story develops. Should the proposed order become finalized, we will work closely with our vendors and be ready to assist our AED customers with their questions about the changes.