FDA has developed this draft guidance to propose select updates to the FDA guidance document “Breakthrough Devices Program Guidance for Industry and Food and Drug Administration Staff”. This guidance proposes select updates to the guidance that clarify how the program may be applicable to certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions in populations impacted by health and/or health care disparities. The existing guidance on the Breakthrough Devices Program remains in effect, in its current form, until this draft guidance is finalized.