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CDRH reports highlight progress in medical device safety, innovation
The Center for Devices and Radiological Health’s recent reports highlight significant advancements in medical device safety, innovation, and regulatory oversight.
On April 17, 2024, the Center for Devices and Radiological Health (CDRH), part of the United States FDA, released two companion reports that comprehensively overview the organization’s unwavering dedication to advancing the core pillars of safety and innovation. The CDRH 2024 Safety and Innovation Reports showcase significant advancements in medical device safety, innovation, and regulatory oversight. These reports also underscore CDRH's commitment to protecting public health while fostering a more flexible regulatory environment and promoting patient-centered care.
CDRH 2024 Innovation Report
The CDRH 2024 Innovation Report emphasizes innovation in the medical device industry. It highlights key initiatives such as the Breakthrough Devices Program and the Safer Technologies Program (STeP), establishing the Digital Health Center of Excellence, utilizing real-world data and evidence (RWD and RWE), and focusing on increasing regulatory flexibility.
Encouraging Innovation
The CDRH 2024 Innovation Report highlights the agency's efforts to encourage innovation in the medical device industry. CDRH has streamlined the review process by implementing various initiatives, increased regulatory flexibility, and fostered collaboration with patients, stakeholders, and innovators. These measures have resulted in a five-fold increase in the number of innovative medical devices authorized annually in the United States since 2009.
STeP
The Breakthrough Devices Program expedites regulatory review and provides timely access to life-saving devices. Since its launch in 2015, the program has authorized over 100 devices. The STeP Program, introduced in 2021, has authorized two devices, further facilitating access to innovative medical technology.
Digital Health Center of Excellence
CDRH's Digital Health Center of Excellence advances responsible and high-quality digital health innovation. It strategically advances digital health science and evidence, tailors regulatory expectations for digital health technologies, and harmonizes international industry standards. Approximately 700 artificial intelligence (AI)/machine learning (ML)-enabled devices have been authorized, showcasing the rapid progress in this field.
Real-World Data and Evidence
CDRH recognizes the importance of RWD and RWE in reducing the time it takes to answer device questions. By utilizing RWD instead of conventional clinical trial data, CDRH has authorized over 100 devices using RWE. Establishing the National Evaluation System for Health Technology (NEST) and engaging with national and regional registries further enhance the utilization of RWD and RWE, promoting evidence-based decision-making.
Increasing Regulatory Flexibility
CDRH has updated key frameworks and policies to increase regulatory flexibility. This includes reforming the Clinical Trial Program to attract industry studies to the US and decrease the median time to clinical trial authorization by 90%. Updated, flexible frameworks for benefit–risk decision-making and the issuance of six guidances have further aligned CDRH with regulatory standards.
CDRH 2024 Safety Report
The CDRH 2024 Safety Report aims to achieve several key objectives in ensuring medical device safety. These objectives include enhancing manufacturing quality, reinforcing post-market surveillance measures, improving data transparency and communication, and strengthening the effectiveness of the medical device recall program.
Enhancing Manufacturing Quality
CDRH collaborates with manufacturers, practitioners, and patients to enhance manufacturing quality through programs like the Case for Quality Program and the Medical Device Single Audit Program (MDSAP). These initiatives improve product quality and compliance, ensuring sustained, predictive practices.
Strengthening Post-Market Surveillance
CDRH has implemented improvements to strengthen post-market surveillance, including establishing the National Evaluation System for Health Technology (NEST) and the Unique Device Identifier (UDI) System. These initiatives enable the evaluation of real-world device performance and the identification of poorly performing devices, ensuring timely interventions and patient safety.
Data Transparency and Communication
CDRH has expanded its capabilities and launched programs such as the International Medical Device Regulators Forum (IMDRF) to harmonize global approaches to medical device oversight. The agency has improved the Manufacturer and User Facility Device Experience (MAUDE) database and introduced the Customer Collaboration Portal to provide accessible and user-friendly information, promoting data transparency and communication.
Medical Device Recall Program
CDRH has taken significant steps to strengthen its medical device recall program. Guidance documents have been issued to manufacturers to ensure device safety and compliance. Patient-centered decision-making has been enhanced by incorporating patient feedback into policies and practices. Additionally, recall data transparency has been increased, and recall review processes have been made more efficient.
Implications for the Industry
The CDRH reports provide valuable insights into the evolving regulatory landscape and the opportunities for innovation and collaboration in the life sciences and healthcare technology industry. They underscore the need for stakeholders to stay informed and engaged as advancements in medical device technology continue to drive improvements in patient care and outcomes.
The CDRH 2024 Innovation and Safety Reports demonstrate the significant progress in advancing medical device safety, innovation, and regulatory oversight. Through initiatives to encourage innovation, increase regulatory flexibility, collaborate with stakeholders, and prioritize patient-centered care, CDRH offers a more flexible regulatory environment and improved patient outcomes.
For the healthcare industry, these reports provide valuable insights into the evolving regulatory landscape and the opportunities for innovation and collaboration — underscoring the need for stakeholders to stay informed and engaged as advancements in medical device technology continue to drive improvements in patient care and outcomes.
As the CDRH continues to prioritize patient safety and encourage innovation, industry stakeholders can expect a more favorable regulatory environment that supports the development of high-quality, safe, and effective medical devices. By aligning regulatory standards, leveraging real-world data, and fostering collaboration, the CDRH aims to advance medical device innovation and ensure the availability of cutting-edge technologies to improve patient lives.
