Warning Letter Roundup & Recap – 13 October 2020
Battelle Memorial Institute, which makes its Critical Care Decontamination System under emergency use authorization from the US FDA, was dinged by the agency for Medical Device Reporting violations. It’s the only device-related warning letter released by the FDA over the past week.
You may also be interested in...
Battelle Memorial Institute, an N95 respirator decontamination system maker, has been back-and-forth with regulators about its Medical Device Reporting protocols, which the US FDA says is lacking. Battelle was granted an emergency use authorization by the agency for its CCDS Critical Care Decontamination System to decontaminate N95 respirators back in March.
Sound abatement foam used in particular bi-level positive airway pressure (BiPAP), continuous positive airway pressure (CPAP), and other mechanical ventilator devices made by Royal Philips could degrade, posing a risk to patients.
The US FDA’s updated regulatory agenda says the agency will release a draft of its revised QSR in June 2021. But industry has seen this song and dance before – so will the FDA finally deliver the goods this time?