Since February 2020, the US Food and Drug Administration (FDA) has been using its Emergency Use Authorization (EUA) powers to allow unapproved drugs and medical devices, or unapproved uses of approved drugs and medical device products, to treat or prevent the spread of COVID-19.
Under the powers set forth at Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C) the FDA has issued EUAs for: in vitro diagnostics, personal protective equipment, “other medical devices,” and therapeutics, as published on the FDA’s website.
Additionally, the FDA has issued two immediately in effect guidance documents: FDA Guidance for Industry (April 2020) Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised), and FDA Guidance for Industry (March 2020) Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency intended to expand the availability of personal protective equipment (PPE) medical devices by reducing the regulatory requirements for medical device products and manufacturers covered by the enforcement policies.
The EUAs and enforcement policies are temporary and will only remain in effect for the duration of the public health emergency related to the COVID-19 outbreak, as declared by the Department of Health and Human Services (HHS).
The FDA continues to seek new ways to increase the availability of necessary drugs, medical devices and therapies that can help with the prevention or treatment of COVID-19. We will continue monitoring the FDA’s evolving policies in order to help clients through these challenging times. If you need additional information or legal advisory for the manufacturing, marketing, distributing, and//or importing of necessary drugs, medical devices and therapies, please contact Ann Marie Gaitan.