Monthly Archives

May 2020

Information for Filing Personal Protective Equipment and Medical Devices During COVID-19

By FDA News

FDA is working with U.S. Government partners, including CDC, and international partners to address the coronavirus disease 2019 (COVID-19) outbreak.

Fast facts

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:

  • entry number (which you can get from your entry filer),
  • port of entry, and
  • other shipment details.

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Understanding the Emergency Use Authorizations

By FDA News

FDA is working with U.S. Government partners, including CDC, and international partners to address the coronavirus disease 2019 (COVID-19) outbreak.

Fast facts

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).

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Re-entry guidance for medical device representatives

By Latest News

AdvaMed Joins AORN, AHA in Issuing “Re-entry Guidance for Health Care Facilities and Medical Device Representatives

Updated news

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.

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