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  1. CDRH Offices

Office of Science and Engineering Laboratories

Ed Margerrison
Ed Margerrison, Ph.D
Director, Office of Science and Engineering Laboratories

Who We Are

OSEL is comprised scientists and engineers who have a broad diversity of expertise from microbiologists to experts in artificial intelligence. We are all dedicated to promoting innovation for the development of new life saving medical devices.

We are organized into approximately 20 program areas, running about 150 research projects through our 4 main technical divisions: Applied Mechanics (DAM), Biomedical Physics (DBP), Biology Chemistry and Materials Science (DBCMS) and Imaging Diagnostics and Software Reliability (DIDSR).

See our video here:

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:

  • Biocompatibility/Toxicology
  • Sterility and Infection Control
  • Artificial Intelligence (AI) / Machine Learning
  • AR/VR - extended reality (XR)
  • Digital Pathology
  • Materials Chemistry and Performance
  • Electromagnetic Compatibility
  • Wireless Compatibility
  • Electrical Safety
  • Medical Imaging
  • MRI Safety
  • Computational Modeling
  • Photoacoustics
  • Medical Alarms
  • Closed Loop Physiological Systems
  • Therapeutic ultrasound
  • Nanotechnology
  • Microfluidics

Office Organization

Contact Us

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 at dice@fda.hhs.gov or 800.638.2041 or 301.796.7100.

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