New Breath-Based Diagnostic Devices to Aid Disease Detection in Underserved Communities: The Bill and Melinda Gates Foundation’s Partnership with FDA’s CDRH and OSEL.

The Bill and Melinda Gates Foundation has recently partnered with the FDA’s Center for Devices and Radiological Health (CDRH) to develop new analytical methods for breath-based diagnostic devices. These devices are aimed at aiding disease detection within medically underserved communities. Ed Margerrison, Ph.D., is the Director of the Office of Science and Engineering Laboratories (OSEL), which 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 goal is to drive innovation in the development of life-saving medical devices.

OSEL is organized into approximately 20 program areas, with a focus 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. As of June 26, 2024, this content remains current.