Medical Device Regulatory Science Research Programs Conducted by OSEL

These Research Programs aim to ensure that patients have access to high quality, safe and effective medical devices. These programs advance regulatory science—the science of developing new tools, standards and approaches to assess the safety, efficacy, quality, and performance of medical devices and radiation-emitting products.

The Office of Science and Engineering Laboratories (OSEL) in CDRH conducts laboratory and field research in the areas of physical, life, and engineering sciences. Our collaborations with academia, health care providers, other government agencies and industry support CDRH efforts to ensure public safety in areas as varied as medical imaging, medical device software, breast implants, and drug eluting stents.

The program areas are:

• Additive Manufacturing
• Artificial Intelligence and Machine Learning (AI/ML)
• Biocompatibility and Toxicology
• Cardiovascular
• Credibility of Computational Models
• Digital Pathology
• Electromagnetic and Electrical Safety
• Emergency Preparedness
• Human Device Interaction
• Materials and Chemical Characterization
• Medical Extended Reality
• Medical Imaging and Diagnostics
• Microfluidics
• Neurology
• Ophthalmology
• Orthopedic Devices
• Patient Monitoring and Control
• Sterility and Infection Control
• Therapeutic Ultrasound

For more information on OSEL, see Office of Science and Engineering Laboratories.