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  5. FDA Roundup: September 9, 2022
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FDA News Release

FDA Roundup: September 9, 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 posted FAQs on Testing for Monkeypox with answers to frequently asked questions relating to the development and performance of tests for monkeypox. These questions and answers provide additional clarity on existing policies and do not introduce any new policies or modify any existing policies. The FAQs include questions and answers regarding the policies described in the FDA's Policy for Monkeypox Tests to Address the Public Health Emergency
  • On Tuesday, September 6, the FDA issued a press release, safety communication and letter to healthcare providers alerting patients, caregivers and health care providers that Philips Respironics (Philips) has recalled certain masks used with BiPAP and CPAP machines due to safety issue with magnets that may affect certain medical devices. Five mask types are affected by this recall: the DreamWisp, DreamWear, Amara View, Wisp and Wisp Youth masks. The recalled masks have magnets that can cause potential injuries or death when use of a recalled mask with magnets interferes with certain implanted metallic medical devices and metallic objects in the body. Users of any BiPAP or CPAP machine should check to see whether their mask is one of the recalled Philips masks.
  • On Tuesday, September 6, the FDA issued a public health alert advising parents and caregivers not to buy or give Mother’s Touch Formula to infants. The product, which is sold at local markets in Kinzers, Loganton, and Gap, Pa. and was available from Mother’s Touch website, is being marketed as an infant formula without the required pre-market notification to the FDA and it does not meet infant formula nutrient requirements for seven nutrients. Parents and caregivers of infants who have used this product and are concerned about the health of their child should contact their health care provider.
  • On September 14, the FDA will host a webinar about the recently published final guidance, Policy for Monkeypox Tests to Address the Public Health Emergency. During this webinar, the FDA will provide highlights of the final guidance and answer questions from webinar attendees.
  • 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 78 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 1109 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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