Science and Research | Medical Devices
CDRH's Regulatory Science Program
Accelerating patient access to innovative, safe, and effective medical devices through best in the world regulatory science
Featured Project
Parkinson’s Disease Is at the Center of a New Tool Developed Through an FDA Partnership.
A new regulatory science tool for Parkinson’s disease research is the result of a partnership between the FDA, VA Ventures, and the Johns Hopkins University School of Medicine. The tool is a dataset that can be used to assess the performance of algorithms used in wearable sensors and to identify digital biomarkers relevant to people with Parkinson’s disease. It may also help innovators develop new ways to measure the progression of Parkinson’s disease and quantify current disease state, potentially leading to earlier treatment and targeted intervention.
REGULATORY SCIENCE AND RESEARCH
Medical Device Regulatory Science Research Programs Conducted by OSEL
Goals, program areas, and initiatives aimed at improving methods and approaches for evaluating, manufacturing, and monitoring medical devices
Read the latest newsletter: Science and Engineering Laboratories Updates
Discover how scientists and engineers promote innovation for the development of new safe and effective medical devices
Catalog of Regulatory Science Tools to Help Assess New Medical Devices
Scientific tools, databases, and information for medical device developers
Jobs, Fellowships, and Collaborations on Medical Device Research
Learn about scientific research job and collaboration opportunities