Devices that qualify for Breakthrough Device designation often involve an ambitious clinical claim, a novel mechanism, and a serious underlying condition, which can require substantial clinical and regulatory investment. Although the FDA’s Breakthrough Devices Program is intended to expedite development and review, only about 15% of designated devices (198 of 1,284) had received FDA marketing authorization as of March 31, 2026.
What Is the Breakthrough Devices Program?
The program is intended to speed up patient access to medical devices that obtain a Breakthrough Device designation. To qualify, a device must meet two criteria:
1. The device provides more effective treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition, and
2. The device meets an innovation requirement: it represents breakthrough technology, it has no approved or cleared alternatives, it offers significant advantages over existing approved or cleared alternatives, or its availability is in the best interest of patients.
Once a device is in the program, its manufacturer has the opportunity for deeper, earlier engagement with FDA review teams, such as through sprint discussions, data development plan meetings, and clinical protocol agreements. The FDA also commits to prioritizing the device’s future submissions. This early engagement often includes not only FDA but also CMS, as the two agencies seek to align their processes to accelerate market access for novel devices. The most recent such effort, the RAPID coverage pathway, synchronizes the FDA and CMS processes from the beginning of the Investigational Device Exemption (IDE) stage.
What are the benefits of a Breakthrough Device designation?
The Breakthrough Devices Program provides medical innovators with “sprint” discussions and other early, frequent FDA interactions to provide feedback on study design, testing, and evidence expectations. Because companies can receive this feedback before making major investments, the result can be greater regulatory predictability, reduced development risk, and potentially hastened reimbursement.
Additionally, a Breakthrough Device designation from the FDA is an early signal that a device addresses a serious, unmet need. The designation tells potential investors that a credible, independent reviewer has already agreed the technology addresses a serious problem no existing device solves, which can make it easier to raise the next funding round.
Why can it be difficult to navigate the Breakthrough Devices Program?
The Breakthrough Devices Program’s enhanced FDA interactions are a double-edged sword. While they can lead to a faster and better regulatory experience, they also require a level of regulatory sophistication that some earlier stage device companies may not have in-house. Sprint discussions, data development plan meetings, and clinical protocol agreements all require carefully prepared submissions and follow-up. Because FDA regulatory consultants are typically involved in these processes, this greater FDA engagement can lead to higher regulatory costs. Even if a company has its own regulatory team, the Breakthrough Devices Program will require substantial investment in time and resources.
Additionally, the Breakthrough Devices Program sets a high clinical bar. It typically requires a study showing CMS that a device has clinical utility, meaning that it affects the care pathway, and that it is more effective than alternatives, rather than just that it has clinical validity, i.e., that it works in the real world. Device companies therefore face pressure to address clinical outcomes and efficacy while the FDA submission is still pending. That can result in a longer and more complex regulatory process.
What is new in the Breakthrough Devices Program?
Under the new RAPID coverage pathway, FDA and CMS review a Breakthrough device’s pivotal trial design and evidence simultaneously, starting as early as the IDE stage. While this is intended to accelerate market access, it also adds complexity earlier in the process. The FDA and CMS are testing data against disparate regulatory standards: FDA is testing for safety and effectiveness, while CMS is testing for real-world clinical utility. So it is a challenge to design a clinical trial that addresses both standards.
How can the HcFocus team help?
HcFocus takes clients from strategy through execution, with decades of experience in regulatory affairs and market access. We work closely with medical device innovators to anticipate the challenges that come with enhanced FDA and CMS engagement so that pursuing Breakthrough designation strengthens a company’s path to market. From structuring a defensible clinical development plan to advising on how and when to discuss clinical outcomes, our team helps innovators build development programs that can withstand FDA scrutiny and carry a device all the way from designation to patients.