FDA relaxes oversight of ventilators in effort to boost supply

Aimed at increasing the availability of ventilators and accessories, the FDA has temporarily relaxed its standards enabling medical device makers to more easily make changes to existing products (e.g. changing suppliers or materials without the normal sign-off process). This includes the use of non-medical device manufacturers which will add substantial capacity.

Hospitals and healthcare professionals may use ventilators normally intended for other environments (e.g., masks used when transporting patients in an ambulance). Healthcare personnel will also be able to use ventilators beyond their indicated shelf lives.

The FDA is encouraging all ventilator makers, domestic or foreign, to apply for emergency use authorization to allow U.S. distribution.

On Friday, March 20, it issued a letter to healthcare providers relaxing its standards of surgical gloves, including allowing the use of nonsterile disposable patient examination gloves for routine patient care and using them beyond the manufacturer-designated shelf life.

https://seekingalpha.com/news/3554042-fda-relaxes-oversight-of-ventilators-in-effort-to-boost-supply