The FDA’s Center for Devices and Radiological Health (CDRH) has recently announced a partnership with the Bill and Melinda Gates Foundation to develop new analytical methods for the creation of breath-based diagnostic devices. These devices aim to aid in disease detection within medically underserved communities. Ed Margerrison, Ph.D., is the Director of the Office of Science and Engineering Laboratories (OSEL), where scientists and engineers work together with expertise ranging from microbiology to artificial intelligence and machine learning. Their goal is to drive innovation in the development of life-saving medical devices.
The Office of Science and Engineering Laboratories (OSEL) at the FDA’s Center for Devices and Radiological Health is organized into approximately 20 program areas and oversees around 150 research projects through its four main technical divisions: Applied Mechanics (DAM), Biomedical Physics (DBP), Biology Chemistry and Materials Science (DBCMS), and Imaging Diagnostics and Software Reliability (DIDSR). Their work focuses on accelerating patient access to innovative, safe, and effective medical devices through regulatory science.
To contact OSEL directly, you can email OSEL_CDRH@fda.hhs.gov. For specific phone numbers and email addresses, you can refer to the CDRH Management Directory by Organization. If you have general questions about medical device regulation, you can reach out to the Division of Industry and Consumer Education. The content is current as of June 26, 2024.
