September 13, 2022 - FDA Roundup: September 13, 2022

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

• On Monday, the FDA reissued the Aug. 19, 2022, letter of authorization for Novavax COVID-19 Vaccine, Adjuvanted to revise the conditions of authorization related to the Vaccine Adverse Event Reporting System (VAERS) reporting requirements for vaccination providers and Novavax, Inc. to include myocarditis and pericarditis. Because some cases of myocarditis or pericarditis following vaccine administration may not meet the definition of serious adverse events, this change will help ensure that cases of myocarditis and pericarditis are reported by Novavax, Inc. and vaccination providers to VAERS. The Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) has also been updated to reflect this revision to the conditions of authorization regarding VAERS reporting requirements. The letter of authorization and revised fact sheet are available on the FDA’s website.
• On Tuesday, the FDA issued a draft guidance, Computer Software Assurance for Production and Quality System Software. This draft guidance provides recommendations on risk-based computer software assurance activities for computers and automated data processing systems that are used as part of medical device production or the quality system. The draft guidance is intended to describe "computer software assurance" as a risk-based approach to establish confidence in the automation used for production or quality systems, and identify where additional rigor may be appropriate, and describe various methods and testing activities that may be applied to establish computer software assurance and provide objective evidence to fulfill regulatory requirements, such as computer software validation requirements in 21 CFR part 820.
• 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 1111 revisions to EUA authorizations.
     

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