• #16 : The FDA grants Traditional Marketing Authorization for COVID- 19 Tests

  • Jan 12 2025
  • Length: 4 mins
  • Podcast

#16 : The FDA grants Traditional Marketing Authorization for COVID- 19 Tests

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  • Summary

  • The FDA initially authorized COVID-19 tests through Emergency Use Authorizations (EUAs) to facilitate their rapid deployment during the pandemic. These tests can continue to be used as long as they are available and not expired. The FDA is now working with test developers to obtain traditional marketing authorization, which involves a more rigorous review process to ensure safety and effectiveness for long-term use. This transition allows tests to be used beyond the time frame allowed under EUAs and is supported by FDA guidance. The FDA considers whether there is reasonable assurance of safety and effectiveness during the traditional premarket review, a higher bar than the EUA process

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