We provide a broad range of FDA compliance services to the Medical Device Industry. Since...
Mdi has been assisting companies worldwide to understand the FDA EUA (emergency use authorisation) for PPE devices (personal protective equipment).
To date, face masks make up over 60% of the PPE requests with CoVI9 IVD tests for the virus and/or the antibodies, and ventilators, face masks and patient gowns making up the 40%. The FDA is constantly making adjustments in their EUA requirements as they learn what is happening in the medical community. mdi has been working closely with the FDA officials to keep up-to-date on the FDA guidance changes.
For more information on the EUA process please contact mdi Consultants by filling out the enquiry form attached to this page.