NEW

Medtronic Receives FDA Approval for Pipeline Flex Embolization Device with Shield Technology

Medtronic plc announced it has received approval from the United States Food and Drug Administration (FDA) for Pipeline Flex Embolization Device with Shield Technology.

CBET Announces Purdue Partnership at MD Expo

Purdue University is pairing its online courses to prepare health care professionals for the Certified Registered Central Service Technician exam with an externship program that gets them the 400 hours of experiential learning they must have to take the exam and become certified.

Avidicare Launches Opragon in a Box

Opragon In a Box is an all-in-one health care ventilation system that creates an ultra-clean zone for infection sensitive surgery.

EarthSafe Launches EvaClean Disposable Surface Disinfection Wipes

EarthSafe has enhanced its end-to-end infection prevention solution with the addition of the EvaClean Dry Wipes System.

FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers

Today, the U.S. Food and Drug Administration took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturers importing personal protective equipment and other devices.

One of FDA’s priorities in combating the COVID-19 pandemic is facilitating access to critical personal protective equipment (PPE) and devices. We are engaging with importers and others involved in the import trade community during this pandemic to facilitate the entry of needed products, including PPE, into the U.S. These instructions to importers clarify the types of PPE that can be imported without engaging with FDA. They also include information about the type of information importers can submit to facilitate their entries. We have adjusted our import screening to further expedite imports of legitimate products and are continually monitoring our import systems to prevent and mitigate any potential issues.

The FDA established a special email inbox, COVID19FDAIMPORTINQUIRIES@fda.hhs.gov, for industry representatives to quickly communicate with the agency and address questions or concerns.

The agency is providing maximum flexibility to those seeking to bring PPE into the U.S. and are ready and available to engage with importers to minimize disruptions during the importing process.

Many companies are stepping up across America to help with manufacturing critical and life-saving medical supplies to strengthen the U.S. response. To support their efforts, we are setting up additional avenues of communication to FDA so they can contact us with any questions or concerns around the clock.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Previous

Next

Submit a Comment

Your email address will not be published. Required fields are marked *

X