FDA Summary: May 20, 2022

For immediate release:

Today, the U.S. Food and Drug Administration provides an at-a-glance summary of news from the agency:

  • On May 19, the FDA released responses to two food additive petitions and a citizen petition seeking agency action on phthalates in food contact applications. The FDA amended its regulations on food additives to no longer provide for the use of most phthalates in food contact applications. The agency also issued a request for information on available safety data and information on current use of certain phthalates in food contact applications.
  • On May 19, the FDA released FDA Voices: “FDA’s “All-in” Approach to Enterprise Transformation,” by Janet Woodcock, MD, Senior Deputy Commissioner, and Meredith Chuk, MD, Senior Medical Advisor, Director, Enterprise Transformation Operation. The article links to the agency’s new business modernization action plan which charts the course for more effective and efficient business processes, increased capabilities to better use the data the agency reviews, and development more coordinated IT systems designed to support these activities. . These cross-agency efforts will also strengthen alignment between strategic goals and agency-wide investments.
  • On May 19, the FDA updated its safety communications and frequently asked questions about recalls of Philips Respironics ventilators, BiPAP devices, and CPAP devices on FDA.gov to provide the latest information. information on medical device reports associated with the failure of polyester-based polyurethane foam.
  • On May 17, the FDA released the updated Know Your Treatment Options for COVID-19 Consumer Update with the latest information on COVID therapies. The FDA has approved two drug treatments for COVID-19 and authorized others for emergency use during this public health emergency.
  • On May 17, the FDA cleared the marketing of BONESUPPORT AB Cerament G, the first device-drug combination product of its kind. The product is a bone void filler (bone graft substitute) to which the antibiotic gentamicin has been added. It is intended to complement systemic antibiotic therapy and surgical debridement in the surgical treatment of osteomyelitis. Osteomyelitis occurs when an infection develops in a bone or spreads to a bone from another part of the body. risk factors for osteomyelitis include diabetes, surgery involving the bones, poor blood supply, recent injury, intravenous drug abuse, or a weakened immune system.
  • The FDA’s Center for Devices and Radiological Health, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research are pleased to invite you to the virtual 2022 Annual Conference on Regulatory Education for Industry. The event will take place from June 6 to June 10, 2022. Learn directly from FDA regulatory experts in the medical product hubs: drugs, devices, and biologics. This course is designed to provide participants with a solid and basic foundation in FDA regulatory requirements. Registration and participation are free. Visit the event page to register. To view the agenda, Click here.
  • COVID-19 testing updates:
    • To date, 433 tests and specimen collection devices are authorized by the FDA under Emergency Use Authorizations (EUAs). These include 300 molecular tests and sample collection devices, 83 antibody tests and other immune response tests, 49 antigen tests and 1 diagnostic breath test. There are 78 molecular clearances and 1 antibody clearance that can be used with home samples. There is 1 EUA for molecular prescription home testing, 2 EUA for antigen prescription home testing, 17 EUA for over-the-counter (OTC) antigen home testing and 3 for home testing Molecular OTCs.
    • The FDA has authorized 27 antigen tests and 7 molecular tests for serial screening programs. The FDA also cleared 978 revisions to EUA clearances.

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The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.


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