Automated external defibrillator maker CardioReady advises caution on the FDA’s new regulatory proposals, urging that increased oversight not stand in the way of public proliferation.
The FDA this month issued a new proposal on the regulatory oversight of automated external defibrillators, but at least 1 medical device maker is worried that enhanced oversight may harm public safety.
Philadelphia-based CardioReady, maker of AED systems, urged that the FDA ensure that any new oversight not jeopardize the proliferation of AEDs, in the interest of public health.