PREP Act Immunity From Liability for COVID-19 Related Medical Equipment

Everyone wants to help by providing necessary equipment to the COVID-19 frontline: hospitals, doctors, nurses, and other healthcare providers battling COVID-19 need ventilators, masks, gowns and other supplies.

Here are answers to commonly asked questions on how companies position themselves to obtain the immunity from liability provided by The Public Readiness and Emergency Preparedness Act (“PREP Act”). Read more about the PREP Act in our earlier alert.

1. I plan to make component parts to be used in ventilators. Do component parts fall within the liability protections of the PREP Act?

ANSWER: Yes. Under the PREP Act, suppliers and licensers of any “component or other article used in the design, development, clinical testing, investigation, or manufacturing of a covered countermeasure” are considered Covered Persons, and the HHS Secretary’s Declaration under the PREP Act extends immunity protections to any device used in a Covered Countermeasure, as well as all components and constituent materials of Covered Countermeasures.

1. My component parts are not cleared by FDA for use in medical devices such as ventilators or masks. Will they be covered under the PREP Act?