Apr 7, 2021

The US Food and Drug Administration (FDA) plans to pursue five areas for near-term focus and implementation in terms of improving the agency’s responsiveness to the coronavirus pandemic as well as future public health emergencies.

The latest FDA announcement follows a summary report issued earlier in 2021 on findings of a third-party review of the agency’s pandemic response efforts, the COVID-19 Pandemic Recovery and Preparedness Plan, or PREPP, which was undertaken from July to December 2020.

Top near-term targets for FDA

Based on the summary report findings as well as current FDA priorities and responsibilities, the agency will initially focus on five PREPP-related efforts, including:

  • Evaluating current Emergency Use Authorization (EUA) processes for medical devices and equipment to determine where improvements are needed in terms of better integrating devices into healthcare systems
  • Reviewing science-based communication efforts to facilitate timely and accurate information for the public
  • Expanding the reach of FDA inspections via next-generation assessment tools including virtual and video platforms
  • Assessing existing systems for supply chain tracking and monitoring to identify gaps and areas for improvement

Additional summary report pandemic and public health emergency preparedness recommendations that FDA may pursue over the longer term include expanding the depth and breadth of the regulator’s partnerships with other US government agencies such as the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH); establishing an agency-wide approach to supporting innovative clinical trial conduct to benefit both efficient trial execution as well as patient/subject access and experience; and defining a framework utilizing real-world data for post-market surveillance and monitoring of COVID-19 vaccines and therapeutic products.

Learn more about US FDA medical device and healthcare regulatory issues:

  • US FDA emergency use pathways for medical devices and IVDs
  • FDA 510(k) consulting for medical device and IVD manufacturers
  • Webinar: FDA Emergency Use Authorizations (EUAs) for medical devices and IVDs

Author

  • Stewart Eisenhart

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