Back To Blog

Proposed FDA Updates for the Breakthrough Devices Program Guidance

The U.S. Food and Drug Administration (FDA) issued a draft guidance, titled Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care. This guidance proposes updates to recommendations included in the guidance Breakthrough Devices Program including additional language to the following parts of Section III:

  • First Criterion – Whether a Device Provides for “More Effective” Treatment or Diagnosis (Section III.B.1)
  • Additional Considerations – Reducing Disparities in Health and Health Care (Section III.B.3)
  • The Designation Review Process (Section III.C)

View the official guidance page to download the draft guidance document. The formal comment period for this guidance ends on December 20, 2022.


 

Article Image
Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care View Guidance Document