- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- The FDA updated the device shortage list and the device discontinuance list on the web page for Medical Device Shortages During the COVID-19 Public Health Emergency. In addition, the FDA is providing information about devices that have been removed from the device shortage list at this time.
- The FDA updated its Supplies of Medical Devices for COVID-19: Frequently Asked Questions web page to provide information about how the FDA determines to remove product codes from the device shortage list and what the FDA is doing to help medical device manufacturers with the global shortage of semiconductor chips.
- The FDA issued a request for information on the food contact uses of fluorinated polyethylene. Fluorination of polyethylene may result in the formation of per- and polyfluoroalkyl substances (PFAS) and this request is part of our continued work to ensure that authorized food contact uses are safe. The FDA is seeking scientific data and information on the current food contact uses of fluorinated polyethylene, consumer dietary exposure that may result from those uses, and safety information on substances that may migrate from fluorinated polyethylene food containers.
- The FDA announced that we would reopen the comment period for the request for information seeking available use and safety information on the remaining phthalates authorized for use as plasticizers in food contact applications. The request for information appeared in the Federal Register on May 19, 2022, with comments due by July 19, 2022. The new deadline for comments will be published in an upcoming Federal Register notice. The FDA is reopening the comment period in response to a request to provide stakeholders with more time to fully consider the request for information and submit comments. Comments about the request for information should be submitted to Regulation.gov and identified with the docket number FDA-2022-N-0571.
- COVID-19 testing updates:
- As of today, 441 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 304 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 80 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
- The FDA has authorized 28 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1032 revisions to EUA authorizations.
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.