Philips has received FDA premarket approval for its over-the-counter defibrillators, HeartStart OnSite and HeartStart Home.
The devices were previously cleared for sale in the U.S. via the 510(k) pathway but now need PMA approval because of regulatory changes implemented by FDA.
Securing the approvals furthers the recovery of Philips’ defibrillator business, which has been operating under a Department of Justice consent decree since 2017 because of prior quality problems.
FDA committed to moving automated external defibrillators to the PMA regulatory pathway in 2015, in part because of quality problems at manufacturers including Philips. Over the preceding decade, FDA received 72,000 reports of device failures and oversaw more than 100 recalls that pulled 2 million products from the market. In 2014, Philips recalled 2,700 HeartStart Home and HeartStart OnSite defibrillators in the U.S.
The PMA positions Philips to continue supplying HeartStart OnSite and HeartStart Home. The devices are the only automated external defibrillators available over the counter in the U.S. and were exempt from the supply ban imposed by the consent decree on public health grounds.
Users of the devices receive step-by-step voice commands and CPR guidance intended to help them treat people who have suffered suspected cardiac arrests. In the absence of similar products, the U.S. government ruled that the benefits of allowing the continued sale of the devices outweighed the quality failings that underpinned the consent decree.
Concerns about Philips’ corrective and preventive action procedures, design verification controls and product specifications at plants in Massachusetts and Washington led to a consent decree with the Department of Justice. Philips is still working its way out from under the consent decree.
“We had hoped that the injunction in Bothell would be lifted already, but I think now we need to be realistic that it can take a couple of months more. We are shipping the defibrillators ... so there’s no real material financial impact to this delay,” Philips CEO Frans van Houten told investors in April.
Philips is already able to ship its full range of defibrillators to customers outside the U.S. but still faces limitations on its activities within the country.