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FDA Roundup: May 3, 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:

  • Monday, the FDA’s Center for Devices and Radiological Health proposed that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act, to require Philips Respironics (“Philips”) to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after November 2015. Philips has an opportunity for an informal hearing before the FDA determines whether to issue an order requiring Philips to submit a plan for the repair, replacement or refund of the purchase price (less a reasonable allowance for use if the device has been in possession of the user for one year or more). This proposal is in addition to the FDA’s previous action under section 518(a) to require Philips to provide notification to customers of the recall and the health risks presented by the recalled devices. Find out more about the Philips Respironics CPAP, BiPAP, and Ventilator recall at Phillips Respironics CPAP, BiPAP, and Ventilators Recalls: Frequently Asked Questions.
  • Monday, the FDA announced organizational changes within the Center for Devices and Radiological Health (CDRH). These changes include:
  • Friday, the FDA informed Abbott Nutrition that the agency has no objection to the company  releasing product to individuals needing urgent, life-sustaining supplies of certain specialty and metabolic formulas on a case-by-case basis that have been on hold since a voluntary recall and FDA warning about the use of powdered infant formula products produced at the company’s Sturgis, MI facility on Feb. 17. The risk of not having certain specialty and metabolic products available could significantly worsen underlying medical conditions, and in some cases, pose life-threatening risks for individuals who rely on these products. In these circumstances, the benefit of allowing parents, in consultation with their healthcare providers, to access these products may outweigh the potential risk of bacterial infection. pose life-threatening risks for individuals who rely on these products. In these circumstances, the benefit of allowing parents, in consultation with their healthcare providers, to access these products may outweigh the potential risk of bacterial infection.
    •  Abbott has confirmed that the company will consider release of these products on a case-by-case basis, depending on product availability and the severity of the individual’s need. Patients and caregivers seeking access to these products should contact Abbott directly to request that a product be made available to them by calling 1-800-881-0876.
    •  It is important for parents and caregivers to understand that any products released on a case-by-case basis at this time were made at Abbott Nutrition’s Sturgis, MI, facility, and that the processes, procedures and conditions that the FDA observed during its inspection of the Sturgis, MI production facility from Jan. 31-March 3, raise concerns that powdered infant formula produced at this facility prior to the FDA’s inspection carry a risk of contamination. Therefore, those seeking access should consult with their healthcare provider in considering whether the benefit of consuming such product outweighs the potential risk of bacterial infection in the user’s particular circumstances.
  • Friday, the FDA warned there are counterfeit versions of the following at-home over-the-counter (OTC) COVID-19 diagnostic tests being distributed or used in the United States:
    • Counterfeit Flowflex COVID-19 Test Kits
    • Counterfeit iHealth COVID-19 Antigen Rapid Test Kits
      These counterfeit tests should not be used or distributed. The FDA’s web page shares information on how to check whether you have a counterfeit test and what to do if you use a counterfeit test. The FDA will update this page to list counterfeit at-home OTC COVID-19 diagnostic tests when significant new information becomes available. Counterfeit COVID-19 tests are tests that are not authorized, cleared or approved by the FDA for distribution or use in the U.S., but are made to look like authorized tests so the users will think they are the real, FDA-authorized test. The performance of these tests has not been adequately established and the FDA is concerned about the risk of false results when people use these unauthorized tests. If you use a counterfeit test, you may risk unknowingly spreading COVID-19 and may delay or stop appropriate medical treatment for COVID-19. The FDA is not aware of any counterfeit tests distributed by the U.S. Government test distribution programs.
  • 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 78 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 949 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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