FDA

FDA Updates Breakthrough Devices Guidance Focused on Health Equity

FDA

The draft guidance proposes updates to clarify how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity, as well as considerations in designating eligible devices that may benefit populations impacted by disparities in health and health care.

The FDA has issued a new draft guidance: Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care. The Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases.

The draft guidance proposes updates to clarify how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity. It also proposes updates to clarify considerations in designating devices, including eligible devices that may benefit populations impacted by disparities in health and health care, as well as how the FDA discloses the Breakthrough status of designated devices once they receive marketing authorization.

“The FDA is committed to advancing the development of safe and effective technologies to meet the needs of all patients and consumers. This draft guidance, once finalized, can help FDA and our stakeholders leverage the interactive nature of the Breakthrough Devices Program to move us closer to achieving our new Strategic Priority to Advance Health Equity, where technologies, including digital health technologies, can help advance better health care, quality of life, and wellness for all communities, and meet the needs of diverse populations,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

Stakeholders can submit comments on the draft guidance up to December 20, 2022. 

 

Related Articles

  • FDA Logo
    FDA Updates Breakthrough Devices Program Guidance

    The updated guidance clarifies how the program applies to medical devices that may address health inequities, as well as those that may increase access to care or provide a non-addictive treatment option to treat pain or addiction. It also clarifies…

  • Chris Fourment
    Decoding FDA Guidance on Decentralized Trials

    Chris Fourment, MD, Senior Vice President, Clinical Strategy at Iterative Health, who specializes in structuring clinical trial programs, discusses the new FDA guidance on decentralized clinical trials, and how DCTs can help spur health and research equity.

  • FDA
    FDA Updates Guidance on Deficiencies in Accordance with Least Burdensome Provisions

    The updated guidance document clarifies what constitutes a statement of the basis for the deficiency and includes examples of well-constructed deficiencies and industry responses to facilitate a more efficient review process.

  • FDA
    FDA Issues Draft Guidance on Computer Software Assurance for Medical Devices

    The new guidance is intended to establish confidence in automation used for production or quality assurance systems and describe various methods and testing activities that may be applied to establish computer software assurance and meet regulatory software validation requirements.