Daily Rules, Proposed Rules, and Notices of the Federal Government
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Registries with medical device data collect data on patients who have been exposed to a medical device. Medical device postmarket surveillance presents unique challenges, related to the diversity and complexity of these products, the iterative nature of product development, the learning curve associated with technology adoption, and the relatively short, product life-cycle. For these reasons, FDA's Center for Devices and Radiological Health (CDRH) uses registries to assess the real-world performance of medical products and procedures; to determine the clinical effectiveness and safety of a test, medical device, procedure, or treatment; to describe the natural history of a problem or disease; and to examine trends of disease, treatment, or product use over time.
To be useful for postmarket device surveillance and assessment of benefits and risks, registries must contain sufficiently detailed patient, device, and procedural data and be linked to meaningful clinical outcomes. CDRH currently engages with more than a dozen registry efforts across a number of device areas, including cardiovascular, orthopedic, ophthalmic, and general surgery products. However, it is not practical or feasible to establish registries for each individual medical device. Development and maintenance of registries with medical device data and consortia of registries needs to be strategic, focused on product areas of high importance, utilize methodologies that integrate data collection into clinical practice, and maximize robust data collection while minimizing resource intensity.
CDRH believes that registry development in targeted product areas will both provide needed postmarket data to enhance public health and be cost-effective for industry, health care providers, and payers. In order to best leverage use of registries with medical device data, participation from all stakeholders, including other government Agencies, academia, professional societies, health care industry organizations, and patient and consumer groups, is needed. The purpose of the public workshop is to facilitate discussion among these key stakeholders in the scientific community on issues related to best practices for medical device registries for use across the Total Product Life Cycle. This public workshop is open to all interested parties. The target audience is professionals in general (academic, healthcare, payers, industry) interested in leveraging registries with medical device data as data and infrastructure for surveillance and studies.
We intend to discuss a large number of issues at the public workshop, including but not limited to the following: (1) Current utilization of registries with medical device data; (2) use of registries with medical device data for postmarket surveillance; (3) registries in relation to the Sentinel provision in the FDA Safety and Innovation Act calling for the expansion of the postmarket risk identification and analysis system to include devices; (4) challenges and opportunities for using registries with medical device data for regulated studies; (5) best practices for governance and structure of registries; (6) business models for sustainable efforts; and (7) strategies and priorities for future use of registries with medical device data.