CDRH Mission and Strategic Initiatives for Medical Device Safety
The Center for Devices and Radiological Health (CDRH) is dedicated to ensuring that patients across the United States have access to medical devices that are safe, effective, and of high quality. By balancing the need for rapid innovation with rigorous safety priorities, the CDRH works to protect and promote public health through a comprehensive regulatory framework.
Key Facts
- Core Vision: Ensuring U.S. patients have access to high-quality, safe, and effective medical devices.
- Patient Integration: 52% of authorizations with clinical studies included patient-reported outcomes (PROs) as of 2024.
- Innovation Milestones: Over 100 devices authorized via the Breakthrough Devices Program since 2015 and 700+ AI/ML-enabled devices since 2020.
- Efficiency Gains: Median time for Investigational Device Exemption (IDE) authorization has decreased by 90% since 2009.
- Regulatory Tools: A catalog of over 150 Regulatory Science Tools (RSTs) is available to expedite device design.
Strategic Priorities (2022–2025)
To maintain its vision of safety and efficacy, the CDRH has established three primary strategic pillars for the 2022–2025 period:
- Promoting a Modern and Diverse Workforce: Building an organization that is proactive, flexible, resilient, and collaborative.
- Enhancing Organizational Agility and Resilience: Redesigning business processes and policies to anticipate future healthcare needs.
- Advancing Health Equity: Developing knowledge and technologies specifically designed to meet the needs of all patients and consumers.
Patient-Centered Development and Partnerships
The CDRH actively integrates the patient voice into the medical device review process. Through the Patient Science and Engagement Program and the Division for Patient-Centered Development, the agency collects scientific evidence on patient experiences. This includes the use of patient-reported outcome (PRO) data; as of 2024, 34% of authorizations with clinical studies used PROs as primary or secondary clinical endpoints.
A cornerstone of this effort is the Patient Engagement Advisory Committee (PEAC), the only advisory committee composed entirely of patients, caregivers, and advocates. Since 2017, PEAC has held seven meetings to provide guidance on complex issues such as AI/ML, AR/VR, cybersecurity vulnerabilities, and health equity.
Furthermore, the Patient and Caregiver Connection allows individuals to share lived experiences with CDRH staff via approximately 20 partner organizations, including Mended Hearts, Breakthrough T1D, and The Michael J. Fox Foundation. The agency also engages in 17 collaborative communities, such as the Heart Valve Collaboratory (HVC) and the National Evaluation System for Health Technology Coordinating Center (NESTcc), the latter of which leverages real-world evidence for innovation.
Driving Innovation and Collaboration
To accelerate the delivery of life-saving technologies, the CDRH employs several expedited pathways and support programs:
- Breakthrough Devices and STeP Programs: These provide priority review and senior management engagement. Since 2015, over 100 devices have been authorized via the Breakthrough program, and two via the Safer Technologies Program (STeP) since 2021.
- Safety and Performance Based Pathway: This allows innovators to assess devices against modern performance criteria rather than outdated predicates in 10 specific device areas.
- Digital Health Center of Excellence (DHCoE): Launched in 2020, this center has seen over 700 AI/ML-enabled devices authorized.
- Total Product Life Cycle Advisory Program (TAP): Launched in early 2023, TAP helps innovators move from concept to commercialization. Currently involving 50 devices in cardiovascular, neurological, and physical medicine, the goal is to reach 325 devices by 2027.
The agency also provides Regulatory Science Tools (RSTs)—methods, models, and datasets that help innovators navigate the design loop. With over 150 tools in the catalog and 20+ added annually, these have been cited in more than 1,250 premarket submissions.
In 2024, the CDRH introduced the Home as a Healthcare Hub initiative. This project involves co-creating a prototype home model with architects, providers, and industry partners to facilitate the adoption of home-use medical devices, with completion expected in late 2024.
Ensuring Safety, Quality, and Resilience
The CDRH utilizes the Case for Quality (CfQ) program to encourage firms to proactively manage risks. A key component, the Voluntary Improvement Program (VIP), has seen participating companies achieve a downward trend in device recalls.
To align with global standards, the FDA issued a final rule in early 2024 amending current good manufacturing requirements to match International Organization for Standardization (ISO) consensus standards. Additionally, the Office of Supply Chain Resilience (OSCR) works to prevent shortages and improve the stability of the U.S. medical device supply chain.
Cybersecurity remains a critical priority. The CDRH provides manufacturers with design recommendations to strengthen device resiliency and issues public safety communications regarding vulnerabilities to prevent delays in patient diagnosis or treatment.
Regulatory Flexibility and Efficiency
The CDRH has significantly streamlined its clinical trial program, reducing the median time for Investigational Device Exemption (IDE) authorization by 90% since 2009. To further reduce timelines, the agency promotes Real-World Evidence (RWE)—data derived from sources outside traditional clinical trials—and has authorized more than 100 devices using this approach.
| Program/Initiative | Primary Goal | Key Metric/Outcome |
|---|---|---|
| Breakthrough Devices | Expedite life-saving devices | 100+ devices authorized since 2015 |
| DHCoE | Digital health innovation | 700+ AI/ML devices authorized since 2020 |
| TAP | Concept-to-commercialization support | Goal of 325 devices by 2027 |
| RST Catalog | Efficient design and redesign | 150+ tools; 1,250+ premarket citations |
| IDE Authorization | Streamline clinical trials | 90% reduction in median time since 2009 |
Historical Challenges and Criticism
The CDRH's regulatory journey has not been without scrutiny. A 1993 House Subcommittee report, "Less Than The Sum Of Its Parts," highlighted structural weaknesses that hindered the agency's ability to protect the public or approve devices timely. Later, a 2010 review suggested that device reviews had lower approval standards than drug reviews, relied too heavily on fast-track processes, and failed to meet Congressionally-mandated classification requirements.
Frequently Asked Questions
What is the primary goal of the CDRH?
The primary goal is to ensure that patients in the U.S. have access to medical devices that are safe, effective, and of high quality while promoting public health through innovation.
How does the CDRH incorporate patient feedback?
The CDRH uses the Patient Science and Engagement Program, the Division for Patient-Centered Development, and the Patient Engagement Advisory Committee (PEAC) to integrate patient perspectives into device reviews and clinical trial designs.
What are Regulatory Science Tools (RSTs)?
RSTs are peer-reviewed methods, models, datasets, and clinical outcome assessments that help innovators more efficiently navigate the design and redesign process for medical devices.
How is the CDRH addressing cybersecurity in medical devices?
The CDRH provides manufacturers with guidelines to integrate cybersecurity into the design process and issues safety communications to the public when vulnerabilities are identified.
What is the "Home as a Healthcare Hub" initiative?
Launched in 2024, this initiative involves creating a prototype home model to reimagine healthcare delivery and encourage the development of devices that make the home an integral part of the healthcare system.