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FDA Roundup: May 6, 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 cleared the Spectrum Medical Quantum Heater-Cooler and the compatible Qura Quantum PureFlow Heat Exchangers used to warm or cool a patient during cardiopulmonary bypass procedures. Instead of using water, the Quantum Heater-Cooler device regulates the temperature of a glycol-based heat transfer fluid (HTF), which then enters the compatible PureFlow heat exchangers to ultimately regulate the temperature of a patient’s circulating blood. The Quantum Heater-Cooler’s HTF demonstrated it mitigates the risk of contamination of the device by suppressing the growth of nontuberculous mycobacteria and other bacteria. This marketing authorization reflects ongoing efforts by the FDA and industry to bring to market innovative devices that can help mitigate known adverse events related to heater-cooler devices.
  • Today, the FDA issued a Letter to Health Care Providers to share information about the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) with the following hemodialysis machines manufactured by Fresenius Medical Care: the 2008T, 2008K2, and 2008K models. The 2008K2 and 2008K models are no longer manufactured, but may still be in clinical use. The source of the NDL PCBAs and NDL PCBs is from the silicone tubing used as a part of the hydraulics in the machine and the dialysate lines. Although the tubing for the dialysate lines does not directly contact the blood, there is the potential for back filtering through the dialyzer into the patient’s blood circulation during treatment.
  • Thursday, the FDA published Enhancing the Safety of Imported Shrimp Through Regulatory Partnerships by co-authors Steve Bloodgood and Fazila Shakir from the Center for Food Safety and Applied Nutrition. 
  • Thursday, through the American Rescue Plan Act of 2021, Congress provided temporary funding for the FDA to develop the capacity to sequence SARS-CoV-2 RNA from wastewater samples and to conduct a sampling and sequencing project through 2022. To facilitate sharing of information about progress on this sequencing effort, the FDA published a public dashboard that graphically presents information from the project. Studies have shown that SARS-CoV-2 (COVID-19) variants of concern from wastewater can be identified 1-2 weeks prior to being detected in clinical samples from the same area, making wastewater surveillance useful for detecting and monitoring SARS-CoV-2 in the population. 
  • Thursday, the FDA issued the final guidance, Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus. This final guidance provides recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with Type 2 Diabetes Mellitus. Such medical devices include, but are not limited to, neurostimulators, and those that mimic or result in anatomical changes similar to those made by bariatric surgical procedures, alter the anatomy and/or physiology of the small intestines, or manipulate the sympathetic nervous system.
  • Wednesday, the FDA authorized an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bamlanivimab. Due to the high frequency of the Omicron variant, bamlanivimab and etesevimab are not currently authorized in any U.S. region. Therefore, these drugs may not be administered for treatment or post-exposure prevention of COVID-19 under the Emergency Use Authorization until further notice by the Agency. However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to bamlanivimab and etesevimab, emerge and become prevalent in the U.S.
  • Wednesday, the FDA released a CDER Conversation with Dr. John Farley, director of the Office of Infectious Diseases, providing useful information that can help health care providers in decision-making regarding Paxlovid. The FDA also released a Patient Eligibility Screening Checklist along with an alphabetized list of other drugs with potentially significant drug interactions.
  • COVID-19 testing updates:
    • As of today, 433 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 298 molecular tests and sample collection devices, 84 antibody and other immune response tests, 50 antigen tests, and one diagnostic breath test. There are 77 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 17 EUAs for antigen over-the-counter (OTC) at-home tests, and three for molecular OTC at-home tests.
    • The FDA has authorized 28 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 957 revisions to EUA authorizations
       

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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, products that give off electronic radiation, and for regulating tobacco products.


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