FDA News Release
FDA Roundup: March 22, 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:
- On March 22, the FDA published a notice to clarify that the effectiveness of certain provisions of the yogurt standard of identity final rule have been stayed. The final rule, published on June 11, 2021, amended the standard of identity for yogurt and revoked the definitions and standards of identity for low fat yogurt and nonfat yogurt.
- On March 21, the FDA issued a Letter to Health Care Personnel to provide recommendations, including conservation strategies, for prefilled 0.9% sodium chloride IV lock/ flush syringes. The FDA is aware the United States is experiencing interruptions in the supply of prefilled 0.9% sodium chloride (saline) intravenous (IV) lock/ flush syringes. Prefilled 0.9% sodium chloride IV lock/ flush syringes are in shortage because of an increase in demand during the COVID-19 public health emergency. Another recent vendor supply chain challenge includes the permanent discontinuance of certain prefilled saline lock/ flush syringes.
- On March 21, the FDA has added prefilled 0.9% sodium chloride IV lock/flush syringes (product code NGT – Saline, Vascular Access Flush) to the device shortage list and the device discontinuance list. The FDA also added certain discontinued surgical apparel (product codes FME, FXP, FYF, LYU and OEA) to the device discontinuance list.
- On March 21, the FDA issued a recall notice about Philips Respironics is recalling certain V60 and V60 Plus ventilators because a subset of these devices had parts that were assembled using an expired adhesive. If the adhesive fails, it could cause the ventilator to stop providing oxygen to the patient. This failure may cause an alarm to notify the health care provider, or it may not sound any alarm at all. The FDA identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences or death.
- On March 21, the FDA released a new user-friendly online Agricultural Water Assessment Builder to help farms understand the proposed requirements for an agricultural water assessment in the Agricultural Water Proposed Rule.
- On March 21, the FDA posted the third in a new quarterly podcast series called TechTalk that focuses on the development and use of new technologies to strengthen the ability of FDA, regulated industry, and others to accelerate prevention, speed outbreak response, and more swiftly adapt to crises that could affect the food supply.
- On March 18, the FDA approved Ztalmy (ganaxolone) to treat seizures associated with cyclin-dependent kinase-like 5 deficiency disorder (CDD) in patients aged 2 and older. This is the first treatment for seizures associated with CDD and the first treatment specifically for CDD. Ztalmy is associated with certain risks, which are described in the prescribing information.
- 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 75 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 892 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