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Please note this is an extract of the original bulletin.

CDRH Issues Updated Final Guidance on the Breakthrough Devices Program

The U.S. Food and Drug Administration (FDA) issued an update to the final guidance: Breakthrough Devices Program. The updates align with the actions outlined in the FDA’s Center for Devices and Radiological Health (CDRH) Strategic Priorities to Advance Health Equity by supporting innovation of new and existing technologies that address health inequities.

The final guidance updates clarify on:

  • How the Breakthrough Devices Program may apply to certain medical devices that promote health equity.
  • Considerations in designating devices, including eligible devices that may support innovation of new and existing technologies that address health inequities.
  • Breakthrough Devices Program may be available for certain non-addictive medical products to treat pain or addiction.
  • How the FDA discloses the Breakthrough status of designated devices once they receive marketing authorization.

More information on this can be found here. The FDA will host a webinar on 14 November at 1 p.m. ET  for the medical device industries that are interested in learning more about the updated final guidance.

 

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