The FDA’s Center for Devices and Radiological Health is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act, to require Philips Respironics to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after November 2015.
Philips has an opportunity for an informal hearing before the FDA determines whether to issue an order requiring Philips to submit a plan for the repair, replacement, or refund of the purchase price (less a reasonable allowance for use if the device has been in possession of the user for one year or more). This proposal is in addition to the FDA’s previous action under section 518(a) to require Philips to provide notification to customers of the recall and the health risks presented by the recalled devices.
The Center for Devices and Radiological Health “is proposing an important step in its continuing efforts to address the impact of the recall on patients. We will take appropriate actions and use the tools available to us to help assure patients receive the relief they need,” says Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a release.