Regulatory Science For AI-Enabled Devices In Medical Imaging: A Perspective From The AI/ML Regulatory Science Research Program At The Office Of Science And Engineering Laboratories (OSEL) At The FDA

As more sophisticated techniques are introduced into artificial intelligence/machine learning (AI/ML) in medical imaging and as new types of AI/ML-enabled devices are tested for the market, new regulatory questions arise. The AI/ML regulatory science research program at the Office of Science and Engineering Laboratories (OSEL) at the FDA performs regulatory research to fill gaps in regulatory science by developing robust test methods and evaluating test methodologies for assessing AI/ML performance both in premarket and real-world settings to reasonably ensure the safety and effectiveness of novel algorithms.

In the first part of this presentation, we will review some of the areas of emphasis, including regulatory science tools and current research projects from the AI/ML regulatory science research program.

In the second part of the presentation, we will focus on the regulatory science issues in imaging raised by natural language processing (NLP) methods and large language models (LLMs). We will briefly outline some of the potential areas of application of NLP/LLM in FDA-regulated devices and seek input from the audience about what types of tools would facilitate the development and evaluation of such devices.

Objectives

Summarize recent initiatives for the regulatory evaluation of AI/ML-enabled medical devices

Describe some of the current research projects from the AI/ML regulatory science research program at OSEL relevant to the design and evaluation of AI/ML-enabled medical imaging devices

Discuss regulatory science issues in imaging raised by natural language processing methods and large language models

Session Chair

Headshot of jeffrey siewerdsen

Jeffrey H. Siewerdsen, PhD, FAAPM, FAIMBE

Professor, Department of Imaging Physics
Director, Surgical Data Science Program, Institute for Data Science in Oncology, The University of Texas MD Anderson Cancer Center
Conference Co-Chair

Speakers

Headshot of Victor Garcia

Victor Garcia, MD

Staff Fellow
Division of Imaging, Diagnostics, and Software Reliability (DIDSR)
Office of Science and Engineering Laboratories (OSEL)
Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration

headshot of berkman sahiner

Berkman Sahiner, PhD

SBRBPAS Expert
Division of Imaging, Diagnostics, and Software Reliability (DIDSR)
Office of Science and Engineering Laboratories (OSEL)
Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration

GRAY CMIMI23

Date

Mon, October 2

Location

Turner Auditorium

Time

2:15 – 3:15 PM ET

Continuing Education

ASRT-RT | CAMPEP-MPCEC | SIIM IIP-CIIP