Final Guidance: FDA Breakthrough Devices Program

The US Food and Drug Administration (FDA) has issued an updated final guidance for its Breakthrough Devices Program, a designation pathway to help expedite devices for debilitating or life-threatening conditions.

Published on 14 September 2023, the guidance includes a raft of updates following the draft guidance issued last October. These include:

• Clarifying how the Program applies to certain innovative medical devices addressing health inequities.
• Clarifying where the Breakthrough Devices Program may apply to certain non-addictive medical products to treat pain or addiction.
• References to resources on evaluating and reporting health equity data within medical device clinical studies.
• Clarifying the FDA’s interpretation of the Program’s designationcriteria, in particular its use of “more effective” (based on all known details about the device, including its potential impact, together with risks and benefits as compared with other treatment options).
• Clarifying the process of how the FDA discloses Breakthrough status of designated devices once marketing authorisation is received.

Access the announcement from the FDA, or visit the FDA website for the full guidance document.