Medical Products Supply Chain Week in Review – September 2021 #3

Alston & Bird

Last week, the White House COVID-19 Response Team indicated the Administration is ready to begin providing booster vaccine doses to eligible Americans. The FDA alerted clinical laboratory staff and health care professionals of false negatives with certain molecular SARS-CoV-2 tests. Please see details for this and other supply chain developments below:

  • On September 22, the President convened a global COVID-19 Summit attended by leaders and partners from around the world. Participants committed to providing over 850 million doses of vaccine and health security financing and infrastructure needs. The President also announced the U.S.’s intent to increase global manufacturing and funding for GAVI, the Vaccine Alliance, to ensure safe shipments of vaccines around the world. World leaders called for more funding for COVAX, equity in distribution of doses around the globe, strengthening supply chain management, and a focus on vaccine readiness. 
  • On September 22, the FDA published guidance for medical device manufacturers regarding issues on safety and new-age technological solutions. 
    • The FDA published a list of authorized devices that utilize artificial intelligence and machine learning in the U.S. based on publicly available information. The listing is meant to assist the public and represents the agency’s thinking in this area.
    • The FDA issued a press release announcing the publication of material safety data from a collaboration with the Emergency Care Research Institute to conduct a systematic review and literature search on the performance of material in implantable medical devices. This included a review of the associated safety summaries, which the FDA is making available to the public to assist manufacturers in selecting safe materials and components for their medical devices. Currently, the available materials include magnesium, polypropylene, polyurethanes, and siloxanes. 
  • On September 23, the FDA posted recommendations and guidance for health care providers and clinical laboratory staff on the performance of certain molecular tests for the SARS-CoV-2 virus. These tests can produce false negatives due to the presence of genetic variants that the test developers did not take into consideration during development. The FDA issued a notice to developers of these tests, establishing new conditions for their EUAs. 
  • On September 23, the Commerce Department released a request for information (RFI) to all participants in the global semiconductor supply chain regarding their supply, demand, and delivery schedules and timelines. The semiconductor chips are utilized in electronics, including medical devices, and businesses in several industries are frustrated by the bottlenecks. In addition to short-term goals, the Administration is also seeking long-term solutions to prevent future shortages. The RFI is voluntary, and the department is seeking responses within 45 days. 
  • On September 24, the White House COVID-19 Response Team reported that there are 20 million Americans eligible for COVID-19 booster shots, and providing the booster doses can begin immediately since the infrastructure needs are currently in place. Decisions on booster doses for the Moderna and J&J vaccines are a high priority for the Administration. 
  • On September 24, the CDC issued recommendations for Pfizer-BioNTech booster shots. The CDC Advisory Committee on Immunization Practices (ACIP) did not recommend booster shots for those in high-risk occupational and institutional settings, but the CDC director, Dr. Rochelle P. Walensky, recommended booster shots in four populations, including those in high-risk settings. The CDC director’s recommendation aligned the CDC’s recommendations with the FDA’s booster authorization

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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