FDA is working with U.S. Government partners, including CDC, and international partners to address the coronavirus disease 2019 (COVID-19) outbreak.
To speed assistance to importers during the COVID-19 pandemic with an urgent need of COVID-19 supplies, please have the necessary information available, such as the:
FDA is working with U.S. Government partners, including CDC, and international partners to address the coronavirus disease 2019 (COVID-19) outbreak.
The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies. There is a lot of confusion from manufacturers, importers, distributors, hospitals, physicians and the general population on what is the EUA. Some people keep claiming they have ”approved” PPE under the EUA. That is totally wrong, the EUA is for authorization, not for approval.
As an Initial Importer our focus is on 2 major topics. First is to make sure we understand where the FDA stands on registration, listing and premarket numbers especially in the context of Emergency Use Authorization (EUA). The second is in regard to importation itself; what information needs to be submitted to the FDA and the US Customs and Border Protection (CBP).
AdvaMed Joins AORN, AHA in Issuing “Re-entry Guidance for Health Care Facilities and Medical Device Representatives
In response to the COVID-19 pandemic, hospitals and surgical facilities nationwide paused elective surgical procedures and other nonemergent and nonessential services, limiting physical access to facilities for nonessential health care personnel, patient visitors, and medical device representatives.
Our services allow manufacturers to spend more time developing their devices rather than searching for distributors, negotiating contracts, and learning regulations.
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