Breakthrough Devices: Recent Changes and Expanding Initiatives by FDA

Breakthrough Devices: Recent Changes and Expanding Initiatives by FDA

The U.S. Food and Drug Administration (FDA) recently issued updates to the final guidance on the Breakthrough Devices Program.

In the dynamic world of healthcare and medical technology, innovation and progress have always been at the forefront. The quest to improve patient care, enhance diagnostic accuracy, and expedite the development of life-changing devices has led to the inception of the FDA’s Breakthrough Devices Program.

This initiative has recently seen some significant changes that seek to speed up medical innovation. In this article, we’ll delve into the FDA’s Breakthrough Devices Program and cover four key changes set to reshape the healthcare technology landscape.



1. Expanding the Reach

The FDA is broadening the horizons of the Breakthrough Devices Program by making it available for technologies that benefit populations impacted by health disparities. This new guidance emphasizes the importance of technologies that address health disparities and promote health equity, ultimately leading to more effective treatment or diagnosis in underserved communities. It also includes non-addictive products or methods to treat pain or addiction, aligning with the FDA’s commitment to combatting the opioid crisis and supporting innovative solutions for pain management and addiction treatment.

2. Clarifying the “More Effective” Criterion

To meet the first Breakthrough criterion, which focuses on providing “more effective treatment or diagnosis,” the FDA is proposing a clarification.

This clarification highlights the importance of considering the totality of available information about the device, including its potential for clinical impact, benefits, and risks. The FDA aims to assess the potential for increased patient benefits when evaluating Breakthrough Designation requests.

3. Addressing Health Disparities

Recognizing the pressing public health need to reduce disparities and improve health outcomes across diverse populations, the FDA has integrated the concept of “Reducing Disparities in Health and Health Care” into the program’s final guidance. By doing so, the FDA underlines the significance of the Breakthrough Program in providing timely access to devices that cater to unmet needs among patient populations experiencing health disparities.

4. Enhanced Transparency

In a move toward transparency, the FDA has added a new paragraph that explains how it discloses information related to a sponsor’s Breakthrough Designation during consultations with Advisory Committees and similar forums. This aims to provide clarity and ensure that all stakeholders are informed.

At a glance — 

The U.S. Food and Drug Administration (FDA) issued updates to the final guidance on the Breakthrough Devices Program.

FDA announced that it will host a webinar for the medical device industry on November 14, 2023 at 1 p.m. ET to discuss the updated final guidance of the Breakthrough Devices Program.

The Center for Devices and Radiological Health (CDRH) launched the volunteer Total Product Life Cycle Advisory Program Pilot beginning with devices that have a granted Breakthrough designation.

The Safer Technologies Program (STeP) is a collaborative program intended to help reduce the time it takes to develop and obtain marketing authorization for eligible devices.


Total Product Lifecycle Advisory Program (TAP)

The TAP Pilot aims to demonstrate the feasibility and advantages of process enhancements in the FDA’s early interactions with stakeholders, aligning with the vision for TAP. The key requirement for enrollment into this Pilot program is that a Breakthrough designation should have been granted. The key objectives of the TAP Pilot include:

Improving Timely Interactions: Enhancing participants’ interactions with the FDA to provide more timely premarket engagement.

Enhancing the Experience: Elevating the overall experience for all stakeholders throughout device development and review, including FDA staff.

Strategic Decision-Making: Facilitating improved strategic decision-making during device development, including early risk identification, assessment, and mitigation.

Solutions-Focused Engagement: Promoting regular, solutions-focused engagement between FDA review teams, participants, and non-FDA stakeholders, such as patients, providers, and payers, from the early stages of device development.

Aligning Expectations: Collaborating to align expectations on evidence generation, enhance submission quality, and streamline the premarket review process.

The long-term vision for TAP is to accelerate the development and widespread patient access to safe, effective, high-quality medical devices of public health significance. A mature TAP also serves to ensure the sustained success of the Breakthrough Devices Program.

The Pilot program is now accepting enrollment requests for both the Office of Cardiovascular Devices (OHT2) and the Office of Neurological and Physical Medicine Devices (OHT5) with a plan to expand for future participation.


Safer Technologies Program (STeP)

STeP is intended for medical devices and diagnostics that would not meet the requirements for the Breakthrough Devices Program but are expected to significantly improve the safety of currently available treatments or diagnostics. The key principles of STeP include:

Reduced Development Time: STeP is designed to expedite the development and marketing authorization process for eligible devices, allowing manufacturers to bring their products to market more quickly.

Interactive Collaboration: Manufacturers can collaborate with FDA experts through various program options, enabling efficient discussions and issue resolution during the premarket review phase.

Timely FDA Feedback: Manufacturers can receive prompt feedback from the FDA, ensuring that issues and questions are addressed promptly, which can be crucial for successful device development.

Effective Communication: STeP offers interactive and timely communication channels, including early engagement on Data Development Plans, sprint discussions, and senior management involvement, as resources permit. These facilitate straightforward and productive interactions with the FDA.

The principles and features of the Safer Technologies Program are outlined in the Safer Technologies for Medical Devices final guidance, providing further details into how the program can benefit manufacturers.


Staying ahead of the curve is essential in this rapidly evolving field. That’s where MDC Associates comes into play. As a trusted partner for CRO Services, Clinical Data Management, Regulatory Affairs, and Quality Systems, we offer strategy and execution support to help diagnostic makers get their IVDs and medical devices to market successfully. With our expertise and your innovation, we can shape the future of healthcare together.

Contact us and let us know what you’re working on.

Stay tuned for more updates and insights as we navigate the exciting medical device innovation and regulation changes. Together, we can drive progress and create a brighter, healthier future for all.

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