Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care

On 21 October 2022 the FDA published the draft guidance for industry and FDA staff. Submit comments by 20 December 2022.

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.

Read more online 
Copyright Widler & Schiemann AG 2022. All Rights Reserved. /