The FDA released a statement on taking action to increase US supplies to support the response to the coronavirus disease 2019 by providing instructions to manufacturers importing personal protective equipment and other devices.
The FDA released a statement on taking action to increase US supplies to support the response to the coronavirus disease 2019 (COVID-19) by providing instructions to manufacturers importing personal protective equipment (PPE) and other devices.
According to the statement, a main priority for the FDA is to facilitate access to critical PPE and devices to combat the COVID-19 pandemic. The FDA plans to engage with importers and others involved in the import trade community to facilitate the entry of needed products into the United States, including PPE.
These instructions are intended to clarify the types of PPE that can be imported without engaging with the FDA and include information about the type of data importers can submit to facilitate their entries, according to the FDA.
A special email inbox has been created for industry representatives to quickly communicate with the agency and address questions or concerns. Anyone interested can reach COVID19FDAIMPORTINQUIRIES@fda.hhs.gov.
Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers [news release]. Silver Springs, MD; FDA: March 24, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-increase-us-supplies-through-instructions-ppe-and?utm_campaign=032420_Statement_FDA%20provides%20instructions%20for%20PPE%20and%20device%20manufacturers%20&utm_medium=email&utm_source=Eloqua. Accessed March 25, 2020.