Just-in-time regulatory support
Our regulatory team, led by Mary McNamara-Cullinane, has been working closely with our clients and FDA on several fronts, including:
- One Emergency Use Authorization to wean patients off ventilators is pending at FDA
- Two ventilator accessory Emergency Use Authorizations
- One remote patient monitoring system Emergency Use Authorization
- Additional Emergency Use Authorizations for disinfectants and sanitizers are currently pendin
In addition, Mary is on two national task forces providing regulatory guidance for respirator and mask manufacturers.