The U.S. Food and Drug Administration’s (FDA) Breakthrough Devices Program is a voluntary initiative designed to expedite the development, assessment, and review of certain medical devices and device-led combination products that offer more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. The program aims to provide patients and healthcare providers with timely access to these medical devices by facilitating their development and prioritizing their review processes.
Eligibility Criteria:
To qualify for the Breakthrough Devices Program, a device must:
- Address a Serious Condition: Be intended for the treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition.
- Offer Significant Advantages: Provide a more effective treatment or diagnosis compared to existing alternatives, based on preliminary clinical evidence.
Additionally, the program may apply to devices that:
- Address health inequities by offering more effective solutions for populations affected by healthcare disparities.
- Provide non-addictive alternatives for pain or addiction treatment, aligning with public health priorities.
Program Features: Benefits for Innovators and Patients
The Breakthrough Devices Program offers a range of benefits that facilitate both device development and patient access:
Priority Review: Applications for Breakthrough Devices, including Premarket Approval (PMA), 510(k), and De Novo submissions, receive expedited review. This reduces the time between submission and decision-making, often cutting months off the process.
Early and Frequent Engagement: Device developers gain access to dedicated FDA staff for guidance on clinical trial designs, evidence generation, and regulatory requirements. This collaboration minimizes delays and ensures that development aligns with FDA expectations.
Flexible Clinical Trial Protocols: Innovative trial designs, such as adaptive trials or the use of real-world evidence, are encouraged to support faster data collection without compromising scientific rigor.
Post-Market Data Collection: In some cases, the FDA allows specific data to be collected after market approval, enabling devices to reach patients sooner while still monitoring safety and efficacy.
The Foundation: The Expedited Access Pathway (EAP) Program
Before the FDA’s Breakthrough Devices Program was introduced, the Expedited Access Pathway (EAP) program paved the way for faster approvals of life-saving medical devices. Launched in 2015, the EAP aimed to address unmet medical needs for patients facing serious or life-threatening conditions by providing a streamlined development and review process for qualifying devices.
The EAP program was designed to help medical devices reach the market faster by focusing on devices that:
- Targeted Serious Conditions: The device was intended for diagnosing or treating life-threatening diseases or conditions that significantly impacted quality of life.
- Addressed Unmet Needs: There were no effective alternatives, or the device showed significant potential to improve upon existing solutions.
- Offered Significant Benefits: Early evidence indicated that the device could enhance patient outcomes meaningfully.
Key Features of the EAP Program:
- Early and ongoing collaboration between device manufacturers and FDA experts to streamline clinical trial design.
- Flexibility in evidence collection, including the option for post-market studies to reduce delays.
- Accelerated regulatory review for devices with promising early data.
The EAP program was instrumental in accelerating devices such as advanced diagnostic tools for rare cancers and innovative prosthetics that improved mobility for individuals with severe injuries.
From EAP to Breakthrough Devices Program
In 2018, the FDA replaced the EAP program with the Breakthrough Devices Program, incorporating its principles while enhancing its scope. The Breakthrough Devices Program not only streamlined the review process for life-saving devices but also expanded eligibility to address broader public health priorities, such as health equity and solutions to the opioid epidemic.
What Changed with the Breakthrough Devices Program?
While the EAP program laid the groundwork for faster device approvals, the Breakthrough Devices Program:
- Expanded Eligibility: It now includes devices that address health disparities and public health priorities, in addition to those treating serious conditions.
- Broadened Support: It offers more robust collaboration and guidance for manufacturers.
- Increased Flexibility: Greater emphasis on innovative trial designs and adaptive methods for evidence generation.
By building on the foundation established by the EAP, the Breakthrough Devices Program continues to accelerate access to transformative medical devices for everyday people while addressing critical health challenges.
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Who Drives the Program? Key Players Behind the FDA’s Breakthrough Devices Program
The success of the FDA’s Breakthrough Devices Program relies on the expertise and efforts of two vital divisions within the agency: the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). These groups play distinct yet complementary roles in ensuring that innovative medical devices and biologics meet rigorous safety and efficacy standards while reaching patients as quickly as possible.
Center for Devices and Radiological Health (CDRH)
CDRH is responsible for overseeing the regulation of most medical devices and radiation-emitting products, such as imaging tools, surgical instruments, and implantable devices. In the context of the Breakthrough Devices Program, CDRH:
- Evaluates devices that qualify for the program and provides manufacturers with guidance on clinical trial designs and evidence requirements.
- Accelerates the review of regulatory submissions, such as Premarket Approval (PMA) applications and 510(k) submissions, for devices designated as Breakthrough.
- Focuses on ensuring that the devices offer significant advantages over existing solutions while maintaining high safety standards.
Center for Biologics Evaluation and Research (CBER)
CBER specializes in regulating biological products, including vaccines, gene therapies, and combination products involving biologics and devices. Within the Breakthrough Devices Program, CBER:
- Oversees biologic-device combinations, such as gene-editing technologies integrated with hardware components.
- Applies its expertise in biologics to evaluate safety and efficacy.
- Collaborates with CDRH when a device involves both mechanical and biologic elements, ensuring a holistic assessment of the product.
While CDRH focuses on devices and CBER specializes in biologics, the two divisions often collaborate on combination products, ensuring that all aspects of innovative therapies are thoroughly reviewed. Their shared mission is to provide timely access to groundbreaking technologies for patients in need while upholding the FDA’s commitment to safety and efficacy.
How This Impacts Patients
By leveraging the expertise of CDRH and CBER, the Breakthrough Devices Program can streamline the approval of life-changing medical technologies. From advanced imaging systems to gene therapies combined with diagnostic tools, the program ensures that patients benefit from the best of science and innovation, delivered faster than ever before.
As of December 31, 2023, the FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) have granted 933 Breakthrough Device designations, including devices originally designated under the Expedited Access Pathway (EAP) program. Of these, CDRH granted 921, and CBER granted 12.
In September 2023, the FDA issued updated final guidance for the Breakthrough Devices Program, clarifying its applicability to devices that may address health inequities and non-addictive products for pain or addiction treatment. This update aligns with the FDA’s commitment to advancing health equity and public health priorities
Recent Success Stories: Transforming Healthcare Through Innovation
The program has already accelerated groundbreaking advancements in multiple fields.
Neuralink’s ‘Blindsight’ Implant
In September 2024, Neuralink, a company specializing in brain-computer interfaces, earned Breakthrough Device designation for its ‘Blindsight’ implant. Designed for individuals who have lost their eyes and optic nerves, the device bypasses damaged pathways to directly stimulate the brain’s visual cortex. While still in its clinical trial phase, early results suggest the potential to restore partial vision, offering hope to thousands of individuals with irreversible blindness.
Roche and Eli Lilly’s Alzheimer’s Blood Test
Roche and Eli Lilly collaborated on the Elecsys pTau217 blood test, which received Breakthrough designation in April 2024. This innovative diagnostic tool detects biomarkers for Alzheimer’s disease in its early stages, years before symptoms emerge. By enabling earlier intervention, the test could transform how the disease is managed, improving outcomes for millions of patients worldwide.
In 2024, the FDA approved a significant number of AI-enabled medical devices, reflecting the growing integration of artificial intelligence into healthcare. As of August 7, 2024, the FDA had authorized 950 AI or machine learning-enabled devices, marking a substantial increase from previous years.
Notable AI-specific devices approved this year include:
- Omron Healthcare’s AI-Powered Atrial Fibrillation Detection: In October 2024, Omron received de novo authorization from the FDA to market home blood pressure monitors equipped with AI-powered atrial fibrillation detection technology.
- Prenosis’ Sepsis Immunoscore: Authorized in 2024, this AI diagnostic test aids in the rapid diagnosis of sepsis and predicts the likelihood of severe cases within 24 hours, enhancing timely and effective treatment.
- Optomed Oyj and AEYE Health’s Portable Retinal Imaging Device: In May 2024, the FDA cleared a portable device that utilizes AI to detect eye conditions, such as diabetic retinopathy, potentially preventing sight loss in diabetic patients.
- Tempus’ ECG-AF Algorithm: In June 2024, Tempus received FDA 510(k) clearance for its AI-based algorithm designed to identify patients at increased risk of atrial fibrillation, aiding in early detection and management.
How Does This Impact You?
The Breakthrough Devices Program isn’t just for specialists or researchers—it directly impacts everyday people by:
- Offering new hope to patients who feel they’ve run out of options.
- Reducing the time it takes for groundbreaking treatments to reach the market.
- Ensuring equitable access to innovative healthcare solutions.
For someone waiting for a life-saving or life-changing medical device, this program represents more than innovation—it represents the possibility of a better life.
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Balancing Rapid Development with Patient Safety
While the Breakthrough Devices Program has facilitated remarkable progress, it also faces challenges. Critics highlight the importance of robust post-market surveillance, particularly for devices that rely on novel mechanisms or limited premarket data. Striking a balance between expedited approval and comprehensive safety evaluation remains a top priority for the FDA. The agency is addressing these concerns through stringent monitoring and continuous updates to its guidelines.
The Road Ahead
As technology evolves, so too does the potential for the Breakthrough Devices Program to change lives. Innovations in artificial intelligence, robotics, and biotechnology are opening doors to possibilities once thought impossible. By fostering collaboration between developers, healthcare providers, and regulators, the FDA is ensuring that these advancements benefit not just a select few but everyone in need.
For everyday people, the program isn’t just about devices—it’s about hope, healing, and the promise of a healthier future.
