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FDA issues final guidance on inspections of medical device establishments

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 US Food and Drug Administration (FDA) today published finalized guidance on inspections of medical device establishments. The final guidance follows a 28 March 2019 draft guidance, satisfying a requirement of the FDA Reauthorization Act of 2017 (FDARA).

The FDARA provision directs FDA to issue guidance specifying how it will implement uniform processes and standards that apply to inspection of both foreign and domestic establishments, other than for-cause inspections. (RELATED: FDA Drafts Guidance on Inspections of Medical Device Establishments, Regulatory Focus 28 March 2019)”
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CBP Continues to Seize Large Number of Counterfeit and Unapproved COVID-19 Products

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

WASHINGTON — U.S. Customs and Border Protection (CBP) continues to identify and seize a large number of counterfeit, unapproved or otherwise substandard COVID-19 products that threaten the health and safety of American consumers.

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Mortality Outcomes of Vertebral Augmentation for Osteoporotic Vertebral Compression Fractures

By Latest News

Fast facts

In a meta-analysis of more than 2 million patients, those with osteoporotic vertebral compression fractures who underwent vertebral augmentation were 22% less likely to die at up to 10 years after treatment than those who received nonsurgical treatment, RSNA 2020

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Radiology JournalRadiology Journal

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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AdvaMed websiteAdvaMed website

COVID-19 tests : Are they all legit ?

By Latest 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

It is very confusing right now and there is a lot of false information circulating. At this time, there is NO test kit available for home testing. As Initial Importer, we make sure to assist manufacturers and distributors to understand the rules and regulations for importing this kind of products.

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FDA websiteFDA website

Importing masks in the US : How to keep track !

By Latest 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

Guidelines from health authorities are changing by the hour. It’s very difficult to keep track. What was true yesterday has been modified today and probably will be tomorrow. We have been in communication with the FDA, and even they are telling us to keep an eye on their website. On Saturday one FDA agent told us this :

This is a very fluid situation and the guidance can change at any time.”

It is the wild wild west! So let’s try to make it easier to understand.

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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FDA websiteFDA website

Adverses Events

By Adverses Events, FDA News

Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions. Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.  To learn more about how to report an adverse event, please visit the FDA website for updated information.