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FDA News

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 The final guidance follows a 28 March 2019 draft guidance, satisfying a requirement of the FDA Reauthorization Act of 2017 (FDARA).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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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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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]

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