August 14, 2020: “The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- The FDA is providing a device shortage list as part of the implementation of section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The device shortage list reflects the categories of devices that the FDA has determined to be in shortage at this time, and will be updated as the COVID-19 pandemic evolves.
In addition, the FDA is providing a list of medical devices for which manufacturing has been permanently discontinued. Under section 506J, manufacturers of certain devices must notify the FDA of an interruption or permanent discontinuance in manufacturing.
The publication of these lists allows for transparency to the public and stakeholders about devices shortages and manufacturing that has been permanently discontinued.
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- The FDA issued an updated FDA COVID-19 Response At-A-Glance Summary that provides a quick look at facts, figures, and highlights of the agency’s response efforts.
- The FDA issued an Emergency Use Authorization (EUA) for the emergency use of Baxter Healthcare Corporation’s REGIOCIT for adult patients being treated with continuous renal replacement therapy (CRRT) and for whom regional citrate anticoagulation is appropriate.
The use of this product under the EUA is limited to critical care settings. CRRT is a “dialysis” treatment that provides renal support for critically ill patients with acute kidney injury.
Baxter Healthcare Corporation’s REGIOCIT is available for use only in healthcare facilities that the company has qualified for receiving this product.
- Testing updates:
- To date, the FDA has currently authorized 213 tests under EUAs; these include 174 molecular tests, 37 antibody tests, and 2 antigen tests.
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.”