Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:
- Today, the FDA provided answers to a set of FAQs about software functions that may be described as clinical decision support (CDS). The FAQs are intended to help sponsors identify whether their CDS software may or may not meet the definition of a medical device, as described in the FDA’s final guidance for Clinical Decision Support Software. Additionally, the FDA updated the list of authorized Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices; totaling 1,016. The list is not a comprehensive resource of medical devices that incorporate AI/ML. The devices in this list have met the FDA’s applicable premarket requirements.
- On Monday, the FDA approved a premarket approval application (PMA) 180-day supplement for the OraQuick Human Immunodeficiency Virus (HIV) Self-Test. This approval represents a labeling change to lower the approved age to individuals who are 14 to 17 years of age and older for the OraQuick HIV Self-Test to provide access to HIV testing to adolescents. The original approval of the OraQuick HIV -Self Test was indicated only for individuals who are 17 years and older.
This is the first approval for an over-the-counter HIV test in adolescents. Availability will help in the detection of HIV among the adolescent population.
The OraQuick HIV Self-Test is a single home-use test to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in human oral fluid specimens. This test kit includes of a test stick (device) to collect the specimen, a test tube (vial) to insert the test stick (device) and complete the test, testing directions, booklet titled, “HIV, Testing and Me”, and access to the OraQuick Support Center to assist users with questions about performing the test, or to connect them with a healthcare provider in their area.
The OraQuick HIV Self-Test is not intended to be used with specimens other than oral fluid. Individuals should obtain a confirmatory test in a medical setting.
Complete instructions for use can be found on the FDA’s website here.
- On Thursday, the FDA Office of Inspections and Investigations published a Viewpoint article titled Partnership in Action: Creating Safeguards for Imported Products Entering the United States in the Pacific Islands by Dan Solis, Assistant Commissioner for Import Operations. The article highlights the FDA’s work in Guam to ensure that imported products entering the U.S. through the Pacific Rim are safe for consumers. The Pacific Rim is a strategically significant location when it comes to ensuring the safety of products bound for consumers in the United States, as a little more than a third of global products coming into our country originate in the Asia-Pacific Region. You can learn more about the FDA’s efforts in the Pacific Islands by listening to OII Podcasts | FDA. The 5-Part series is called, Guam Series: FDA Presence and Impact in Pacific Islands.
- On Thursday, the FDA updated the outbreak advisory for Salmonella Typhimurium infections linked to cucumbers with additional cases. The FDA’s investigation remains ongoing.
- On Thursday, the FDA approved Tryngolza (olezarsen), used with diet, to reduce triglycerides (TG) in adults with familial chylomicronemia syndrome (FCS). FCS is a rare, genetic disorder that prevents the body from breaking down fats (TG) in the bloodstream. People with FCS can have TG levels in the thousands. These high TG levels can cause severe abdominal pain, inflammation of the pancreas (acute pancreatitis), and fatty deposits in the skin (xanthomas). Some of these symptoms, specifically acute pancreatitis, can be life-threatening. This is a first-in-class approval, meaning Tryngolza uses a new mechanism of action, or works differently in the body, than other therapies currently used to treat FCS. The most common adverse reactions were injection site reactions, decreased platelet count, and arthralgia.
- On Thursday, the FDA re-evaluated its determination from October 2, 2024, on the status of the tirzepatide shortage. The agency issued a new decision determining the tirzepatide injection shortage is resolved. The FDA’s determination is based on its analysis of all the information before the agency.
- On Wednesday, the FDA posted the latest videoExternal Link Disclaimer in the FDA In Your Day series. This one focuses on pertussis, also known as whooping cough, and what consumers can do to protect themselves and those around them.
- On Wednesday, the FDA approved Ryoncil (remestemcel-L-rknd) an allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, for steroid-refractory acute graft versus host disease (SR-aGVHD) in pediatric patients 2 months of age and older. Ryoncil is the first FDA-approved MSC therapy. The most common nonlaboratory adverse reactions (incidence ≥20%) were viral infectious disorders, bacterial infectious disorders, infection – pathogen unspecified, pyrexia, hemorrhage, edema, abdominal pain and hypertension.
- On Wednesday, the FDA approved Ensacove (ensartinib, Xcovery Holdings, Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor. The most common adverse reactions (≥20%) were rash, musculoskeletal pain, constipation, cough, pruritis, nausea, edema, pyrexia, and fatigue.
- On Wednesday, the FDA shared our latest testing results for per- and polyfluoroalkyl (PFAS) substances in clams as follow up to the agency’s findings in the 2022 PFAS in seafood survey. Between October 2022 and September 2024, the FDA collected and analyzed 12 samples of processed clams with China as the country of origin. All 12 samples had detectable levels of at least one type of PFAS.
- On Wednesday, the FDA issued a letter to food manufacturers that Amanita muscaria (A. muscaria), its extracts, and certain of its constituents (muscimol, ibotenic acid, and muscarine) are not authorized for use as ingredients in conventional food. A. muscaria and its constituents have been used in foods intended to have hallucinogenic effects, sometimes marketed as “psychedelic edibles”, “legal psychedelics” or “mushroom edibles”. After reviewing the available information about A. muscaria and its constituents, the FDA concluded that they do not meet the safety standard for use in food and that their use as food ingredients may be harmful. We also recommend that people avoid eating foods with these ingredients. The FDA’s assessment of chemicals in the food supply is part of our commitment to food safety and public health.
- On Wednesday, the FDA updated the advisory for the outbreak of E. coli illnesses linked to certain sizes and brands of organic whole and baby carrots supplied by Grimmway Farms. According to CDC, as of December 18, 2024, this outbreak is over. The FDA conducted inspections at Grimmway Farms and collected environmental samples. Two environmental samples collected outside were positive for Shiga toxin-producing E. coli (STEC). Although both strains of E. coli detected in the samples are capable of causing human illness, neither match the strain of E. coli causing illnesses in this outbreak. The FDA is working with Grimmway Farms on corrective and preventive actions. The FDA’s investigation is complete.
- On Tuesday, the FDA and the U.S. Department of Agriculture announced a charter that details how the two agencies work together to determine the appropriate agency to regulate the small number of animal biologicals for which jurisdiction may be unclear. Representatives from the FDA and USDA originally signed a Memorandum of Understanding in 2013 that outlined which animal biologicals each would regulate. Since 2013, science has continued to advance, and the jurisdiction of some products is not clear under the MOU. The charter includes a flowchart to help clarify which agency will regulate a given product, as well as information on how to request a jurisdiction determination from the FDA and USDA for animal biologicals.
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