Wednesday, July 21, 2021

FDA’s Budget: New Medical Device Supply Chain and Shortages Program

The investments outlined in the FDA's FY 2022 budget include a new Resilient Supply Chain and Shortages Prevention Program.

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FDA - Center for Devices and Radiological Health

The New Resilient Supply Chain and Shortages Prevention Program

The U.S. Food and Drug Administration (FDA) has requested, as part of our budget proposal, a package of legislative proposals designed to bolster the FDA's authorities to further its mission to protect and promote public health. Notable proposals include efforts to expand the FDA's authorities for device shortages to assure a more resilient domestic supply chain and help reduce dependence on foreign production.

The investments outlined in the FDA's Fiscal Year (FY) 2022 budget include $21.6 million for a new Resilient Supply Chain and Shortages Prevention Program (RSCSPP) in the FDA's Center for Devices and Radiological Health (CDRH). This funding will:

  • Provide, for the first time, resources to establish a permanent program for U.S. supply chain resilience and shortages prevention or mitigation for medical devices
  • Help to stand up this program, which will build on the work done to implement the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) during the COVID-19 public health emergency
  • Focus on strengthening the domestic supply chain through investments in preventive measures, identifying potential medical product supply short-falls, continuing surveillance, and rapid intervention
  • Strengthen CDRH's capability to respond in everyday situations, as well as in emergencies

To ensure the U.S. is properly prepared now, and in the future, we must take action to secure our medical device supply chain, including related materials, parts, and components. The FDA recognizes that this will take resources and expanded authority.

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Questions?

If you have questions about the new Resilient Supply Chain and Shortages Prevention Program, contact the Division of Industry and Consumer Education.


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