Office of Science and Engineering Laboratories Also referred to as: OSEL
Update: June 26, 2024
The FDA’s Center for Devices and Radiological Health (CDRH) is partnering with the Bill and Melinda Gates Foundation to create new analytical methods to help the development of breath-based diagnostic devices for disease detection in medically underserved populations. Read the full CDRH Statement about the announcement.
Ed Margerrison, Ph.D
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
- Digital Pathology
- Electromagnetic and Electrical Safety
- Emergency Preparedness
- Human Device Interaction
- Materials and Characterization
- Medical Acoustics
- Medical Extended Reality
- Medical Imaging and Diagnostics
- Microfluidics
- Neurology
- Ophthalmology
- Orthopedic Devices
- Patient Monitoring and Control
- Pediatric and Perinatal Devices
- Sterility and Infection Control
Office Organization
- 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)
Contact Us
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.