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FDA Roundup: September 20, 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 alerted medical device users about a potential cybersecurity risk for the Medtronic MiniMed 600 Series Insulin Pump System. There is a potential issue associated with the communication protocol for the pump system that could allow unauthorized access to the pump system. A nearby person other than the user or care partner may be able to gain access to the pump while the pump is being paired with other system components. If unauthorized access occurs, the pump’s communication protocol could be compromised, which may cause the pump to deliver too much or too little insulin.
  • On Friday, the FDA granted accelerated approval to Skysona (elivaldogene autotemcel), the first cell-based gene therapy indicated to slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD). Childhood CALD is a life-threatening genetic condition caused by mutations in the ABCD1 gene, which lead to buildup of chemicals that cause inflammation and damage in the brain. The condition affects only males and typically presents with symptoms of inattention, behavior difficulties and neurologic dysfunction between 4 to 10 years of age. Left untreated, symptoms typically progress to neurologic disability and ultimately death in the second decade of life. Prior to the approval of Skysona, there was no FDA-approved treatment, but standard-of-care treatment for CALD is allogeneic hematopoietic stem cell transplant (allo-HSCT), where the patient receives stem cells from a donor. Given challenges finding an appropriate donor and toxicity associated with allo-HSCT, there is a substantial unmet medical need for boys with CALD. This application was granted a rare pediatric disease priority review voucher (PRV), in addition to receiving orphan drug and Breakthrough Therapy designations by the FDA. Information may be found on the FDA’s web site.
  • On Friday, the FDA authorized the marketing of Phagenyx System, which delivers electrical stimulation to the oropharynx, part of the throat at the back of the mouth behind the oral cavity. It is used as an aid in the treatment of stroke patients who experience dysphagia (difficulty in swallowing) caused by stroke.
  • On Thursday, the FDA issued an updated Letter to Health Care Providers to ensure health care providers in the operating room setting are aware of the voluntary recall initiated by Medtronic for the risk of airway obstruction with the NIM CONTACT Reinforced EMG Endotracheal Tube and NIM Standard Reinforced EMG Endotracheal Tube.
  • COVID-19 testing updates:
    • As of today, 438 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 301 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 antigen tests, and 1 diagnostic breath test. There are 79 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, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
    • The FDA has authorized 31 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1116 revisions to EUA authorization.

Related Information

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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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