The U.S. FDA’s Center for Devices and Radiological Health is proposing an order be issued that would require Philips Respironics to submit a plan for the repair, replacement, or refund of the purchase price of the recalled devices manufactured after November 2015, which includes millions of ventilators.
In an update shared Monday, the agency proposed issuing an order that would require Philips to repair, replace or refund all 5.2 million ventilators, CPAP and BiPAP machines and other devices included in the June 2021 Class I recall—a process that the devicemaker has already begun, albeit slowly.
Before the FDA makes the order official, Philips will have the chance to participate in an informal hearing with the agency. If it decides to proceed with the order after the hearing, Philips would have to submit a plan detailing how it will complete the repairs, replacements and refunds—the last of which allows for the subtraction of a “reasonable allowance for use if the device has been in possession of the user for one year or more,” per the FDA.
The regulator has the power to make the order under section 518(b) of the Federal Food, Drug and Cosmetic Act, which allows the FDA to step in amid a company’s recall efforts if it determines that a federal order is the only practical way to ensure the safety issue is properly taken care of.
Read the full article at Fierce Biotech.