- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- On Dec. 23, the FDA updated the Device Shortage List on our web page that lists Medical Device Shortages During the COVID-19 Public Health Emergency. Specifically, the FDA added the following device types in the testing supplies and equipment category: pipette tips (product codes LXG and PPM) and micro pipettes (product code JRC). The FDA also added clarifying notes and links to more resources in the “Additional Information” column, as well as adding clarity to the categories, such as grouping gloves under “Personal Protective Equipment – Gloves.” The device shortage list reflects the categories of devices the FDA has determined to be in shortage at this time, and the FDA will continue to update the list as the COVID-19 public health emergency evolves. In addition, the FDA is posting a new web page, Supplies of Medical Devices for COVID-19: Frequently Asked Questions.
- The FDA posted an updated letter of authorization, health care provider fact sheet and frequently asked questions regarding the number of Pfizer-BioNTech doses in a vial. These updates are consistent with previous FDA advice that it would be acceptable to use every full dose obtainable (the sixth, or possibly even a seventh) from each vial, pending resolution of the issue. However, since the vaccine does not contain preservative, it is critical to note that any further remaining product that does not constitute a full dose should not be pooled from multiple vials to create one.
- Testing updates:
- As of Dec. 28, 309 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 235 molecular tests and sample collection devices, 63 antibody tests, and 11 antigen tests. There are 32 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter (OTC) at-home antigen test.
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.
- Jane Hubbard