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| The FDA wants to tighten regulations on automatic external defibrillators like Philips' HeartStart FRx.--Courtesy of Philips |
Implantable defibrillators must go through the FDA's rigorous PMA process before they can be sold, but their external counterparts, tacked to walls in shopping malls and airports around the country, have a much easier path to market, and the agency wants to change that.
The FDA says it has received more than 45,000 failure reports for automated external defibrillators since 2005, and now it is proposing stricter regulations on the devices that would require manufacturers to submit clinical proof of safety and undergo random inspections. The agency is allotting 90 days for public comment on the proposal.
"Automated external defibrillators save lives," CDRH Chief Scientist William Maisel said in a statement. "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 wants clinical trial data for defibrillators already on the market, which can be time-consuming to amass, but Maisel said most companies with devices cleared for sale already have safety and efficacy numbers to back them up and that only a couple would have to launch studies, The New York Times reports.
For manufacturers of external defibrillators, including Philips Healthcare ($PHG) and Zoll Medical, the switch from 510(k) clearance to a full PMA would mean paying $220,000 instead of $5,000 for approval, according to the Times, but the FDA says the companies would only have to pay that money once to cover multiple models.
The agency is proposing a similar regulatory revision for metal-on-metal hip implants, all of which went through the 510(k) clearance process to get on the market. The FDA wants to require devicemakers to submit data demonstrating the safety and effectiveness of their all-metal hips within 90 days of the rule taking effect, and, if companies refuse or fail to convince the FDA, their devices would be banned from sale.
- read the FDA's statement
- here's the NYT story