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FDA Roundup: May 14, 2024

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 Monday, the FDA’s Office of Science and Engineering Laboratories launched an improved online Regulatory Science Tool (RST) Catalog to enhance search and browse capability as well as allow for long-term growth in published tools. The RST Catalog is now organized by research program and device type, cross referenced by both program and RST category, and an online portal for many OSEL-developed applications including the Device and Material Safety Evaluation Library. The RST Catalog will continue to provide peer-reviewed resources for medical device companies and innovators.
  • On Monday, the FDA announced the virtual Medical Device Sterilization Town Hall – Sterilization Method Selection for New and Existing Devices that will be held on Thursday, May 23, 2024, at 1-2:15 p.m. ET. During this town hall, the FDA will host a panel discussion for what to consider when choosing a sterilization method or changing methods. Registration is not required to attend. Please submit any questions to MedicalDeviceSterilization@fda.hhs.gov at least one week in advance.   
  • On Monday, the FDA issued a safety communication to warn patients, caregivers, and health care providers not to use Cue Health’s COVID-19 Tests due to an increased risk of false results. The FDA had also issued a Warning Letter to Cue Health after an inspection revealed that the company made changes to these tests and that the changes reduced the reliability of the test to detect SARS-CoV-2 virus. 
  • On Monday, the FDA added 191 devices to the list of artificial intelligence and machine learning (AI/ML)-enabled devices legally marketed in the United States by 510(k) clearance, granted De Novo request, or premarket approval. With this update, the list includes 882 AI/ML-enabled medical devices authorized through March 31, 2024. This list is not meant to be an exhaustive or comprehensive resource of AI/ML-enabled medical devices. Rather, it is a list of AI/ML-enabled devices across medical disciplines, based on publicly available information. The FDA maintains this list to increase transparency about AI/ML-enabled devices in this rapidly progressing field.
  • On Friday, the FDA posted a new video in the “FDA In Your Day” series. In this video, Principal Deputy Commissioner Dr. Namandjé Bumpus discusses biosimilars, anti-choking protocols, home as a health care hub initiative, and high blood pressure education month.
  • On Friday, the FDA announced that it does not intend to enforce new animal drug approval requirements for products compounded from GS-441524, when prescribed by a veterinarian for a specific cat patient for the treatment of Feline Infectious Peritonitis, under the conditions listed in Guidance for Industry (GFI) #256 Compounding Animal Drugs from Bulk Drug Substances.
  • On Friday, the FDA announced it had conditionally approved the first torsemide animal drug for dogs. UpCard-CA1 (torsemide oral solution) was conditionally approved for use with concurrent therapy with pimobendan, spironolactone, and an angiotensin-converting enzyme (ACE) inhibitor for the management of pulmonary edema (fluid build-up in lungs) in dogs with congestive heart failure caused by myxomatous mitral valve disease (MMVD).

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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, radiation-emitting electronic products, and for regulating tobacco products.



 

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