FDA Proposes Order Directing Philips Respironics To Submit Plan for Handling Recalled Devices
May 5, 2022 at 12:27 PM EST
Ramping up its scrutiny of a widespread recall, the FDA’s Center for Devices and Radiological Health (CDRH) May 2 proposed to issue a Section 518(b) order directing Philips Respironics to submit a plan for repairing, replacing or refunding the purchase price of a range of ventilators, continuous positive airway pressure (CPAP) machines, and bi-level positive airway pressure (B... Read More
