ALSO REFERRED TO AS OSEL
Director, Office of Science and Engineering Laboratories
Who We Are
The Office of Science and Engineering Laboratories (OSEL) is composed of scientists and engineers who have a broad diversity of expertise from microbiology to artificial intelligence and machine learning. We are all dedicated to promoting innovation for the development of new lifesaving medical devices.
We are organized into approximately 20 program areas, running about 150 research projects through our four main technical divisions: Applied Mechanics (DAM), Biomedical Physics (DBP), Biology Chemistry and Materials Science (DBCMS) and Imaging Diagnostics and Software Reliability (DIDSR).
Here’s a snapshot of the research being done within OSEL:
What We Do
We accelerate patient access to innovative, safe and effective medical devices through best-in-the-world regulatory science. We undertake regulatory research in the following program areas:
- Additive Manufacturing
- Artificial Intelligence and Machine Learning (AI/ML)
- Biocompatibility and Toxicology
- Cardiovascular Program
- Credibility of Computational Models
- Digital Pathology
- Electromagnetic and Electrical Safety
- Emergency Preparedness
- Human-Device Interaction
- Laser Therapeutics
- Materials Performance
- Medical Extended Reality (AR/VR)
- Medical Imaging and Diagnostics
- Microbiology and Infection Control
- Orthopedic Devices
- Patient Monitoring and Control
- Postmarket Device Performance Assessment
- Therapeutic Ultrasound
- Division of Applied Mechanics (DAM)
- Division of Biomedical Physics (DBP)
- Division of Biology, Chemistry, and Materials Science (DBCMS)
- Division of Imaging, Diagnostics, and Software Reliability (DIDSR)
To contact us directly, email OSEL_CDRH@fda.hhs.gov.
For specific phone numbers and email, see the CDRH Management Directory by Organization.
For general questions about medical devices regulation, contact the Division of Industry and Consumer Education.