To address ventilator shortages due to the COVID-19 pandemic, the FDA released guidance outlining relaxed enforcement policies for ventilator modifications and uses. The guidance allows modifications to FDA-cleared ventilators without premarket review for indications, claims, hardware, software, and materials. It also allows extended shelf lives for breathing circuits and use of non-approved ventilators under emergency use authorizations. The FDA encourages labeling any modifications clearly and contacting them for EUA review of non-approved ventilator devices.