USA: FDA issues guidance on use of CPAP devices as ventilators during COVID-19 outbreak
The Food and Drug Administration (FDA) has released temporary guidance allowing hospitals to repurpose continuous positive airway pressure (CPAP) devices to assist with the shortage of ventilators in the United States. The guidance authorizes hospitals and manufacturers to make certain changes to existing CPAP machines so they can be used as respiratory devices.
Ventilators normally used in ambulatory services, now can be used in long term care. The FDA also extended an invitation to auto manufacturers to help create new ventilators and their parts as needed. This revised policy plans to use ‘enforcement discretion’ for modifications to FDA-cleared devices. Traditionally, manufacturers' modifications to ventilators would trigger an additional pre-market review, which could delay deployment.
These new guidelines help ventilator manufacturers receive expedited clearance, allowing increased availability of ventilators during this crisis period when ‘maximum regulatory flexibility’ is at its peak. Non-US manufacturers are also encouraged to contact the Agency about emergency authorizations to distribute ventilators in the USA.
How TSG can help
TSG’s consultants have been keeping track of the most recent policy modifications from the FDA during this public health emergency. We can determine the best regulatory strategy to address the data requirements for FDA’s review, as well as develop and review data claims and labelling of ventilators to comply with FDA regulations.
Complete our contact form for an informal chat with one of our consultants.