COVID-19 Emergency regulations and requirements for streamlining the manufacturer and distribution of ventilators

FDA has cleared the way for manufacturers of existing of Class II “cleared” ventilator technologies, and manufacturers of foreign ventilator technologies, to modify those technologies in order to fill the supply-side shortage in the number of ventilators health officials are anticipating the US will need to treat patients who are suffering from respiratory failure or insufficiency caused by the COVID-19 Virus.

See FDA’s Advisory Letter to Health Care Providers HERE.

See FDA’s Official Enforcement Policy HERE.

Additionally, the FDA has issued Emergency Use Authorizations (EUA) soliciting proposals from manufacturers not already involved in the development and manufacture of ventilator technologies for the design of emergency alternatives to existing, cleared ventilator technology.

See the official FDA Authorization HERE.

Although the requirements for modifications and introductions of medical device technology is reduced and streamlined, there are still requirements and hoops that must be met even under the EUA.

See the official technical guidelines, standards and requirements for the design and manufacture of ventilators under the FDA’s Emergency Use Authorization HERE.

Liability protection for manufacturers and distributors of ventilators needed to fill existing and anticipated COVD-19 supply shortfalls

To encourage and facilitate the development and manufacture of new ventilator technologies to fill the significant shortfall of ventilators nationwide caused by the COVID-19 virus and its associated critical respiratory symptoms, the federal government affords individuals and business immunity from tort liability associated with these emergency technologies.

See the FDA’s Publication regarding immunity from liability under the EUA HERE.

The Public Readiness and Emergency Preparedness (PREP) Act provides immunity to manufacturers and distributors of ventilators under the FDA’s Emergency Use Authorization (EUA) so long as they meet the requirements set forth in an appropriate Declaration from the Department of Health and Human Services (DHS).

See the DHS Declaration providing immunity from liability to individuals and organizations manufacturing and distributing ventilators under the EUA HERE.

See the the PREP glossary of terms for determining coverage under the DHS Declaration HERE.