Monthly Archives

March 2020

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).

[Read More]

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.

Recalls

By FDA NewsNo Comments

The FDA posts summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death.  Please visit the FDA website for updated information.

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

FDA is working with U.S. Government partners, including the U.S. Centers for Disease Control and Prevention (CDC), and international partners to closely monitor an outbreak caused by a novel (new) coronavirus first identified in Wuhan City, Hubei Province, China.

The virus has been named “SARS-CoV-2” and the disease it causes has been named “coronavirus disease 2019” (abbreviated “COVID-19”).

While the U.S. Government considers this a serious public health concern, based on current information, the CDC has determined that the immediate health risk from COVID-19 to the general American public is considered low at this time. People in communities where ongoing community spread with the virus that causes COVID-19 has been reported are at elevated risk of exposure. Travelers returning from affected international locations, close contacts of persons with COVID-19, and healthcare workers caring for patients with COVID-19 are at elevated risk of exposure.  [Read More]

FDA websiteFDA website

Society for Cardiovascular Angiography & Interventions (SCAI) 2020

By Conferences and Seminars

Each year, SCAI brings together 2,000 physicians, cardiovascular professionals, hospital administrators, academics, and industry professionals from around the world to share knowledge, clinical expertise, and the latest medical advances, with the single goal of advancing care to Save and Enhance Lives.

Date : May 13-16, 2020

Venue: Hyatt Regency, Atlanta

One of the best meeting to discuss the M-CATH micro catheter in challenging lesions.

FIME 2020

By Conferences and Seminars

As the largest collection of healthcare product manufacturers and service providers under one roof, FIME is your one-stop shop for all your healthcare sourcing and procurement needs

Date : postponed, 2020

Venue: Miami Beach Convention Center, Miami

Dawa Medical LLC will be there to discuss your needs for US Agent, Initial Importer, Distribution and Warehousing.

Transcatheter Cardiovascular Therapeutics (TCT) 2020

By Conferences and Seminars

Transcatheter Cardiovascular Therapeutics (TCT) is the world’s largest and most important educational meeting specializing in interventional cardiovascular medicine. For 32 years, TCT has been the center of cutting-edge educational content, showcasing the latest advances in current therapies and clinical research.

Date : September 23-27, 2020

Venue: Miami Beach Convention Center, Miami

A great opportunity to talk about the M-CATH micro catheter.