The FDA is mulling stricter approval regulations for external defibrillators following dozens of recalls involving hundreds of thousands of the devices. In documents posted late last week, the agency said it wants defibrillators makers to submit data and undergo manufacturing inspections before new devices can hit the market. An expert panel will consider the FDA's request; the FDA doesn't have to follow the panel's recommendations, though it usually does.
The devices are currently approved under the 510(k) pathway, which allows products similar to others already approved to hit the market without extensive testing. Devicemakers, of course, don't want tougher regulation of the devices (the new rules don't include implantable defibrillators). But manufacturing flaws in the design of defibrillators have led to 23,000 reports of device problems in the last five years. In some instances, the devices didn't deliver the shock necessary to treat a person in cardiac arrest. The FDA estimates that about 500 lives are saved each year by people who use the devices, which can be found in schools, airports and many other public areas.
Late last year the agency sent a letter to all defibrillator manufacturers encouraging them to consult with the FDA on ways they can avoid common device design flaws.
- read the AP report