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FDA Publishes Updated Guidance for Breakthrough Devices Program

On September 15, 2023, the U.S. Food and Drug Administration (FDA) updated and posted the Final Guidance for Industry and Food and Drug Administration Staff: Breakthrough Devices Program. This guidance updates the previous version of the guidance, of the same title, issued on December 18, 2018.

What is the Breakthrough Devices Program?

The Breakthrough Devices Program is a voluntary program that is intended to expedite the review of breakthrough technologies, or technologies that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. In this final guidance, FDA has expanded the scope of this program to include technologies that benefit populations impacted by health and/or health disparities. Additionally, non-addictive technologies to treat pain or addiction can be considered for this program. It is available for devices and device-led combination products which are subject to review under a premarket approval application (PMA), premarket notification (510(k)) or De Novo classification request (“De Novo request”).

Some of the key benefits of this program include: 1) more interactive and timely communication with FDA as compared to standard interactions; 2) the acceptance of a greater level of uncertainty in the premarket phase and, therefore, the ability to define certain requirements that could be met post-market; 3) flexibility regarding clinical study design; 4) senior management engagement; and 5) priority review.

Changes to the Guidance

The overall intent of the Breakthrough program, the benefits afforded to Breakthrough technologies and the administrative aspects of the program are largely unchanged. The changes made between the draft and final guidance include the following:

  • As mentioned above, technologies that benefit populations impacted by health and/or health disparities and non-addictive technologies to treat pain or addiction can now be considered for this program.
  • Sponsors must meet first Breakthrough criterion—whether a device provides for “more effective” treatment or diagnosis. Regarding the amount of evidence that needs to be presented to meet this criterion, FDA clarifies that they consider the totality of the information when making this assessment. This includes the device function, potential for technical and clinical success, potential for a clinically meaningful impact and the potential benefits and risks.
  • A new “additional consideration” has been added to the final guidance titled “Reducing Disparities in Heath and Health Care.” In this section, FDA provides specific examples of health care disparities that may exist, and they state that the Breakthrough Program could be used to help provide more timely access to devices that address unmet needs of patient populations that experience health disparities. Additionally, they clarify that if technologies address social factors, phenotypic variations, pathophysiology and or response to treatment, this can be considered when evaluating whether a device may provide more effective treatment—including the potential to be more effective in certain patient populations. Lastly, the guidance notes that the ability of a technology to improve accessibility to quality health care can be taken into consideration when FDA evaluates whether the technology may provide a more effective treatment.
  • A new paragraph has been added that explains to what extent FDA discloses information related to a sponsor’s Breakthrough Designation.

For More Information

The FDA website for the Breakthrough Devices Program has the following information:

  • Guidance
  • FDA webinar link – webinar on Tuesday, November 14, 2023 at 1pm ET
  • Number of Breakthrough Device Designations granted
  • List of Breakthrough Devices that have received market authorization

You can access this information at: https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program.

How can NAMSA Help?

NAMSA is the industry leader in driving successful regulatory outcomes through daily interactions with the FDA. Our Regulatory team is comprised of former FDA staff and industry experts who uniquely understand the regulatory requirements and agency nuances when writing and supporting submissions.

We have extensive experience helping Sponsors navigate the Breakthrough Devices Program for both Class II and III devices. We have found this program to be very successful in helping our Clients reach consensus with FDA in a timely manner, which helps expedite their get-to-market strategy.

If you are interested in speaking with us about FDA-related activities or other global regulatory strategies, please Contact Us or learn more about our Regulatory experts at namsa.com/subject-matter-experts.

Carla Wiese

Carla M. Wiese, BS-Mech Eng

Carla Wiese has over 22 years’ experience in the medical device industry in project management, research and development and regulatory disciplines. Prior to joining NAMSA in 2017, Carla held positions with Boston Scientific, Solace Therapeutics, and most recently the U.S. Food and Drug Administration (FDA). At the FDA, Ms. Wiese served as Lead Reviewer for cardiovascular devices before becoming the Program Director of the Early Feasibility Studies (EFS) Program where she oversaw development of new review strategies to help increase EFS in the United States.