The FDA today said it will require makers of automated external defibrillators like Royal Philips (NYSE:PHG), Zoll Medical and Physio-Control to put their devices through its rigorous pre-market approval protocol.
The federal safety watchdog said it wants to make sure that AEDs, portable medical devices used to treat cardiac arrhythmias on the spot, are safe and reliable, citing a spate of recalls over the last decade and the 10s of thousands of medical device reports it’s received during that time.
"Automated external defibrillators save lives," said Dr. William Maisel, acting director of the FDA of the Office of Device Evaluation in the FDA’s Center for Devices & Radiological Health, said in prepared remarks. "These changes to the way these devices are reviewed will allow us to more closely monitor how they are designed and manufactured. This will go a long way towards correcting long-standing problems and ultimately improving the reliability of these devices."
The FDA said it received roughly 72,000 reports of failed AEDs from January 2005 through September of last year. Manufacturers have issued 111 recalls affecting more than 2 million AEDs since 2005, the agency said.
"By requiring premarket approval for these devices, the FDA will receive important information about an AED manufacturer’s quality systems information. The FDA will also conduct inspections of manufacturers’ facilities prior to approval. After approval, manufacturers will be required to submit to the FDA any changes made to the devices that affect safety or effectiveness, and annual reports on device performance," the agency said in a press release.
The new PMA requirements are slated to go into effect July 29, 2016, provided AED makers tell the agency before April 29of their intent to file for approval. The FDA said it doesn’t plan to enforce the PM requirement for currently marketed "necessary" AED accessories until January 29, 2020.
DeviceTalks Minnesota's leadership track is designed to provide attendees with insights on topics such as:
Use code SAVE15 to save 15%!