Science & Engineering Laboratories
Discover how scientists and engineers in the Office of Science and Engineering Laboratories (OSEL) at the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) promote innovation for the development of new lifesaving medical devices.
OSEL Program Highlights
FDA, Veterans Health Administration Collaborate to Help Accelerate Medical Device Innovation and Advancement of Care
The FDA and the Veterans Health Administration (VHA) are announcing a collaboration intended to help accelerate American medical device innovation to further improve and benefit public health. Veteran Affairs’ VA Ventures Innovation Institute, located in Seattle, will host up to 12 FDA staff to foster robust collaborations between the two agencies. The FDA staff will focus on the regulatory science — the science for evaluating the benefits and risks of new products — while VA staff will provide clinical context for test development and provide hands-on training and other immersive experiences for innovators wishing to utilize the tools.
Read the press release
Catalog of Regulatory Science Tools to Help Assess New Medical Devices
The Catalog of Regulatory Science Tools collates a variety of regulatory science tools that CDRH’s OSEL developed, with new tools added as they become available.
We’ve added new instructions for use for these regulatory science tools to help you find the tool resources in one place:
Browse the Catalog of Regulatory Science Tools.
|
Recent Publication
- Petersen, E. J., Elliott, J. T., Bancos, S., Caldwell, B., Khajotia, S. S., Kleinstreuer, N. C., Margerrison, E. and Pfeifer, C. (2022) “Predictive alternative methods for assessing biocompatibility of dental materials: A NIST-NIDCR workshop report”, ALTEX - Alternatives to animal experimentation, 39(3), pp. 522–524. doi: 10.14573/altex.2206241.
Contact OSEL
If you have questions about OSEL, email OSEL_CDRH@fda.hhs.gov.
You can also subscribe to CDRH Science for regular email updates on CDRH’s scientific topics and OSEL.
About CDRH’s Office of Science and Engineering Laboratories (OSEL): The mission of Office of Science and Engineering Laboratories (OSEL) in the FDA’s Center for Devices and Radiological Health (CDRH) is to advance the science needed to evaluate the benefits and risks of emerging medical technologies and devices. OSEL conducts laboratory and field research in the areas of physical, life, and engineering sciences that leads to innovative, science-based approaches or methodologies (tools) to help assess the safety or effectiveness of medical devices and radiation-emitting products. OSEL’s collaborations with academia, health care providers, other government agencies, and industry support CDRH efforts to ensure public safety in areas as varied as medical imaging, medical device software, breast implants, and augmented reality surgical navigation systems.
|