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Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- Today, the FDA issued an emergency use authorization (EUA) for CorDx, Inc.’s CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test, a single use test intended to detect and differentiate influenza A and B (commonly known as flu) and SARS-CoV-2 (the virus that causes COVID-19), in individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five days of symptom onset when tested at least twice over three days with at least 48 hours between tests. Validation data to support the EUA of this test was gathered through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), established as a collaboration between the FDA and the NIH. The test can be used for people aged 14 years or older with a self-collected nasal swab specimens and aged 2 years or older when an adult collects the nasal swab specimens.
- On Wednesday, the FDA announced the availability of a draft guidance for industry titled “New Dietary Ingredient Notification Master Files for Dietary Supplements.” This draft guidance responds to the dietary supplement industry’s requests for specific guidance on recommendations about Master Files for new dietary ingredient notifications (NDINs).
- On Wednesday, the FDA issued an import alert for Jiangsu Caina Medical Co. Ltd. for not meeting device quality system requirements, to prevent these products from entering the U.S. The FDA will continue to provide updates about the ongoing evaluation of quality and performance issues related to plastic syringes made in China, including their ability to deliver the correct dose of medication when used alone or with other medical devices such as infusion pumps. In addition, the FDA will continue to work with stakeholders, including other federal agencies, medical device manufacturers, and health care organizations to ensure the safety of syringes being used in the U.S.
- On Wednesday, the FDA issued an emergency use authorization (EUA) for OSANG LLC’s QuickFinder COVID-19/Flu Antigen Self Test, a single use test intended to detect and differentiate influenza A and B (commonly known as flu) and SARS-CoV-2 (the virus that causes COVID-19), in individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first four days of symptom onset when tested at least twice over three days with at least 48 hours between tests. Validation data to support the EUA of this test was gathered through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), established as a collaboration between the FDA and the NIH. The test can be used for people aged 14 years or older with a self-collected nasal swab specimen and aged 2 years or older when an adult collects the nasal swab specimens.
- On Tuesday, the FDA granted authorization for Prenosis, Inc.’s Sepsis ImmunoScore, an Artificial Intelligence/Machine Learning-Based Software that identifies patients at risk for having or developing sepsis. Each year, according to the Centers for Disease Control and Prevention, at least 1.7 million adults in the U.S. develop sepsis, and nearly 270,000 die as a result.
“Sepsis is a serious and sometimes deadly complication. Technologies developed to help prevent this condition have the potential to provide a significant benefit to patients,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “To help ensure the safety and effectiveness of software as a medical device, the FDA’s authorization of the Prenosis Sepsis ImmunoScore software establishes specific premarket and postmarket requirements for this device type, including software validation and clinical performance testing for the intended use before they are authorized for marketing.”
The device uses data from the patient's electronic health record in conjunction with other laboratory findings and clinical assessments to aid in the risk assessment for presence of or progression to sepsis within 24 hours of assessing a patient who has been admitted to the emergency department or hospital and meets certain other criteria. It should not be used as the sole basis to determine the presence of sepsis.
On Tuesday, the FDA published a CDER Conversation highlighting the system of postmarket surveillance and risk assessment programs to identify and evaluate adverse drug reactions and medication errors that did not appear during the drug development process, and to learn more about known adverse drug reactions. Gerald J. Dal Pan, M.D., M.H.S, Director of CDER’s Office of Surveillance and Epidemiology (OSE), discusses current priorities to develop and implement processes needed to support efficient and effective postmarket safety.
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