CPAP Devices Can Be Used as Ventilators During Coronavirus Outbreak, FDA Guidance Says

Published in Member Communities on March 24, 2020

On March 22, it was announced that new temporary guidance from the FDA allows hospitals to re-purpose existing products such as CPAP devices as ventilators in an effort to meet major shortages in the United States during the coronavirus outbreak.

The guidance allows hospitals and manufacturers to make certain modifications to existing devices, or to production lines, to create more respiratory devices.

Ventilators normally used in other environments, such as ambulances, could be used for long-term care, the guidance says. It covers devices that aren't traditionally used for long-term care.

The guidance also would allow non-medical device companies, such as auto manufacturers, to start making ventilator parts.

The agency 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.

The guidance means "America can make more ventilators during this crisis,” Health and Human Services Secretary Alex Azar said in a release.

The guidance also aims to create "maximum regulatory flexibility" while "still providing crucial FDA oversight," FDA Commissioner Stephen Hahn said in a release.

FDA is also encouraging manufacturers, including foreign ones, to contact the agency about emergency authorizations to distribute ventilators in the United States.

Original Updates:

• https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-ventilators-and-accessories-and-other-respiratory-devices-during-coronavirus
• https://subscriber.politicopro.com/health-care/whiteboard/2020/03/cpap-devices-can-be-used-as-ventilators-during-coronavirus-outbreak-fda-guidance-says-3978335