FDA News Release
FDA Roundup: April 5, 2022
- For Immediate Release:
Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- Today, the FDA announced sotrovimab is no longer authorized to treat COVID-19 in any U.S. region due to increases in the proportion of COVID-19 cases caused by the Omicron BA.2 sub-variant. The Centers for Disease Control and Prevention (CDC) Nowcast data estimates that the proportion of COVID-19 cases caused by the Omicron BA.2 variant is above 50% in all Department of Health and Human Services (HHS) U.S. regions. Data included in the health care provider fact sheet shows the authorized dose of sotrovimab is unlikely to be effective against the BA.2 sub-variant.
- Today, the FDA issued a Safety Communication to provide new information supporting the transition to fully disposable duodenoscopes, and those with disposable components, as well as new information on completed postmarket surveillance studies— also known as 522 studies. The final results of the postmarket surveillance studies on fixed endcap design indicate that as high as 6.6% of samples tested positive with high concern organisms after contamination. High concern organisms are defined as organisms that are more often associated with disease, such as E. coli, and Pseudomonas contamination after reprocessing.
- On April 4, the FDA issued a public health alert advising consumers and retailers to avoid potentially contaminated raw oysters from Canada. The agency is working with federal, state and local officials and with Canadian public health authorities regarding a norovirus outbreak linked to raw oysters from British Columbia, Canada. The FDA has confirmed that potentially contaminated raw oysters harvested in the south and central parts of Baynes Sound, British Columbia, Canada, were distributed to restaurants and retailers in California, Colorado, Florida, Hawaii, Illinois, Massachusetts, Minnesota, New Jersey, Nevada, New York, Oregon, Texas and Washington states. It is possible that additional states received these oysters through further distribution within the U.S. The FDA and the states conducted a trace forward investigation to determine where the raw oysters were distributed and to ensure they’re removed from the food supply.
- On April 4, the FDA issued a Letter to Health Care Providers to ensure that health care providers and users are aware of the change in reprocessing methods for certain urological endoscopes manufactured by Karl Storz. The FDA is aware that the current reprocessing instructions for certain urological endoscopes manufactured by Karl Storz are inadequate and are being updated by the manufacturer. The affected urological endoscopes include cystoscopes, ureteroscopes, cystourethroscopes and ureterorenoscopes, used for viewing and accessing the urinary tract.
- COVID-19 testing updates:
- As of today, 425 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 293 molecular tests and sample collection devices, 84 antibody and other immune response tests and 48 antigen tests. There are 74 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, 15 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 9 molecular tests for serial screening programs. The FDA has also authorized 911 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.
- FDA Office of Media Affairs