FDA Lets Some Changes To Monitoring Tools Bypass Clearance Process During COVID-19 Pandemic
Manufacturers can expand the remote-use capabilities of patient-monitoring devices like thermometers and stethoscopes without alerting the US FDA during the coronavirus crisis, a new guidance document from the agency says.
You may also be interested in...
US telehealth companies are seeing skyrocketing demand for devices and services, which offers opportunities and challenges during this COVID-19 crisis.
The US agency is relaxing some regulatory requirements on facial masks and actively pursuing ways to reprocess N95 respirators used by medical staff under an immediately-in-effect guidance document.
Companies offering OTC sample collection kits to help diagnose COVID-19 quickly fell under scrutiny in the US because the FDA hasn’t authorized any OTC tests.