The Office of Science and Engineering Labs (OSEL) in the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has one mission:

Accelerate patient access to innovative, safe, and effective medical devices through best-in-the-world regulatory science.

Discover how OSEL’s scientists and engineers promote innovation for the development of new lifesaving medical devices.

Ed Margerrison, Director, OSEL

Medical Device Regulatory Science Research: 20 Programs, One Focus

OSEL conducts laboratory and field research in the areas of physical, life, and engineering sciences. Its 20 research programs aim to ensure that patients have access to high quality, safe, and effective medical devices.

Our collaborations with academia, health care providers, other government agencies and industry support our efforts to ensure public safety in areas as varied as medical imaging, medical device software, breast implants, and drug eluting stents. Browse the Research Program Areas.

Accelerating Medical Device Innovation with Regulatory Science Tools

"These tools reduce the need for device developers to design ad-hoc test methods and allow them to focus their limited resources on how well their new product works, not how well it may be tested."  –Dr. Jeff Shuren, CDRH Director

The Catalog of Regulatory Science Tools collates a variety of regulatory science tools that CDRH’s Office of Science and Engineering Labs (OSEL) has developed, with new tools added as they become available. These methods expand the scope of innovative science-based approaches to improve the development and assessment of emerging medical technologies.

The catalog includes more than 100 tools, including laboratory methods, tissue-mimicking phantoms, and computational modelling and simulations. Browse the Catalog of Regulatory Science Tools.

Biocompatibility Assessment Resource Center

In March 2021, the FDA launched an online Biocompatibility Resource Center with step-by-step recommendations compiled from existing FDA guidance for use while preparing medical device submissions for the FDA. These recommendations include:

- Basics of Biocompatibility
- Biocompatibility Endpoint Tables
- Documenting How a Test Article Compares to the Proposed Medical Device
- What Should I Put in a Test Report?

This resource is not intended to replace any policies specified in an FDA guidance. Browse the Biocompatibility Assessment Resource Center.

FDA Science Forum

The 2021 FDA Science Forum will be held virtually on May 26-27, 2021. The Forum offers an exciting opportunity for the public to view the unique scientific research and collaborative efforts of the FDA’s 11,000 scientists. You'll get a chance to see first-hand how the FDA's researchers are using novel science and technologies to inform its regulatory decision-making—and drive innovation. This year’s keynote speaker is NIAID Director Anthony Fauci, M.D. 

The public, industry, academia, patient advocates, other government agencies, and current and potential collaborators are welcome to join virtually and learn about the critical contributions the FDA's regulatory science makes to product quality and safety.

Register to attend the FDA Science Forum.

5G-Enabled Medical Device Workgroup

 In November 2020, the Medical Device Innovation Consortium (MDIC) established a workgroup on 5G-enabled medical devices to facilitate the future development of novel technology based on 5G telecommunication networks while ensuring patient safety.

The MDIC 5G-enabled health care technologies workgroup recently held a meeting on May 6, 2021. The meeting included a talk by Kevin Donahue from Verizon and a brief update about the two recently formed subgroups for developing educational material and executing a landscape analysis.

For more information, including how to join the effort, refer to the MDIC’s 5G-Enabled Health Technologies page.