 
Science & Engineering Laboratories
Discover how scientists and engineers in the Office of Science and Engineering Laboratories (OSEL) at the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) promote innovation for the development of new safe and effective medical devices.
OSEL Program Highlights
Updates to the Catalog of Regulatory Science Tools to Help Assess New Medical Devices
The Catalog of Regulatory Science Tools is a peer-reviewed resource with over 100 tools, including phantoms and lab methods, that medical device developers can use to help assess new medical technologies. The tools reduce the need for device developers to design ad-hoc test methods and allow them to focus their limited resources on assessing how well their new product works, not how to perform the assessment.
The FDA updated the catalog to add 3 new tools and update 5 tools:
New:
- Additively Manufactured Mock Spine Cage Designs for Mechanical Performance Test Assessments: STL Set 1
- Lumbar Integrated Fixation Devices-Best Practices for Biomechanical Evaluation under Fatigue Loading
- VICTRE: In Silico Breast Imaging Pipeline
Updated:
- Endoscope Geometric Distortion- A Method for Quantitative Evaluation
- Infrared Thermographs- Methods for Evaluating Laboratory Performance
- Method for Estimating the Likelihood of Wireless Coexistence
- Modified Dot-Blot Method to Evaluate Personal Protective Equipment
- Verification Test Problems for Cardiac Electrophysiology Modeling Software
Browse the Catalog of Regulatory Science Tools.
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The FDA Joins the Medical Innovations in Extended Reality IUCRC
We recently joined the Medical Innovations in Extended Reality (MIXR) Industry-University Collaborative Research Center (IUCRC)! MIXR-IUCRC will help accelerate the development of safe and effective virtual reality, augmented reality, and other immersive medical technologies—referred to as “extended reality”—for use in clinical trials and eventually widespread use in medical care.
Advances in computing and displays have enabled a recent surge in low-cost, extended reality devices, including augmented reality (AR) and virtual reality (VR). These new capabilities have resulted in substantial interest in the development of medical extended reality (MXR) devices. While MXR devices present new opportunities for patient care, there are major regulatory science gaps and challenges in the ways that these devices are shown to be safe and effective.
IUCRCs are supported by the National Science Foundation (NSF) and are designed to jumpstart breakthrough research by enabling close and sustained engagement between industry innovators, world-class academic teams, and government agencies.
For more information about or to contact our MXR Program, visit Medical Extended Reality Program: Research on Medical Extended Reality-Based Medical Devices.
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Contact OSEL
If you have questions about OSEL, email OSEL_CDRH@fda.hhs.gov.
You can also subscribe to CDRH Science for regular email updates on CDRH’s scientific topics and OSEL.
About CDRH’s Office of Science and Engineering Laboratories:
The mission of Office of Science and Engineering Laboratories (OSEL) in the FDA’s Center for Devices and Radiological Health (CDRH) is to advance the science needed to evaluate the benefits and risks of emerging medical technologies and devices. OSEL conducts laboratory and field research in the areas of physical, life, and engineering sciences that leads to innovative, science-based approaches or methodologies (tools) to help assess the safety or effectiveness of medical devices and radiation-emitting products. OSEL’s 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 augmented reality surgical navigation systems. Read more about Office of Science and Engineering Laboratories.
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