Regulation of Medical Imaging and Radiation Therapy Devices and Imaging Science Research at the FDA
Date
The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) is responsible for the safety and effectiveness of medical devices marketed in the U.S. This presentation will discuss FDA’s responsibilities and research related to radiological imaging and therapy devices, including:
· CDRH’s premarket review programs and available resources,
· Performance testing for imaging biomarkers and computer-assist devices,
· Regulation of radiation therapy devices, and
· CDRH medical imaging and imaging science research activities.
Visit our website at http://www.ucsfstanfordcersi.org or contact [email protected] with any questions.
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811 America/Los_Angeles publicType
Time Duration
Location
The U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) is responsible for the safety and effectiveness of medical devices marketed in the U.S. This presentation will discuss FDA’s responsibilities and research related to radiological imaging and therapy devices, including:
· CDRH’s premarket review programs and available resources,
· Performance testing for imaging biomarkers and computer-assist devices,
· Regulation of radiation therapy devices, and
· CDRH medical imaging and imaging science research activities.
Visit our website at http://www.ucsfstanfordcersi.org or contact [email protected] with any questions.
Click to Register for event
Speakers
The talks will summarize FDA premarket regulations applicable to investigational use and commercial medical imaging and radiation therapy devices, highlighting resources available to assist investigators and manufacturers. The regulatory focus will be related to the validation (i.e., assessing safety and effectiveness) of image processing software, imaging biomarkers, and the radiation therapy devices. CDRH has an imaging science research laboratory with research activities in imaging physics, image analysis, diagnostics, and software reliability. As part of this talk, we will describe FDA research efforts currently underway that support the regulatory mission of the Agency as it relate to medical imaging, including an overview of our regulatory research portfolio in advancing the understanding of imaging technologies, computer-assist devices and approaches to their evaluation. A more in depth look at CDRH research activities related to the development of an assessment framework for evaluating the technical performance of quantitative imaging tools and biomarkers in CDRH will be included.
Robert Ochs is the Director of the Division of Radiological Health within the U.S. Food and Drug Administration, Center for Devices and Radiological Health. He received his Ph.D. in Biomedical Physics from the University of California, Los Angeles. The Division of Radiological Health is responsible for pre-market review, compliance, and post-market surveillance for radiological medical devices (e.g., CT, MRI, mammography, ultrasound, radiation oncology devices, and radiological image analysis software) as well as the regulation of non-medical radiation emitting electronic products (e.g., lasers, microwaves). The division actively participates in regulatory research, policy development, international standards development, and professional committees to advance the safety and effectiveness of radiological devices. His interests include translational research and outreach to support the validation of new diagnostic imaging equipment and image analysis software.
Nicholas Petrick is the Acting Director for the Division of Imaging, Diagnostics and Software Reliability (DIDSR) within the U.S. Food and Drug Administration, Center for Devices and Radiological Health and has been appointed to the federal Senior Biomedical Research Service (SBRS). He earned his B.S. degree from Rochester Institute of Technology in Electrical Engineering and his M.S. and Ph.D degrees from the University of Michigan in Electrical Engineering Systems. Dr. Petrick’s areas of interest include imagine processing, machine learning and medical physics. His current research focuses on quantitative imaging and computer-aided diagnosis with an emphasis on the development of validation and assessment methods for these technologies.
Michael O’Hara is the Deputy Division Director of the Division of Radiological Health in the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH). The division is responsible for the pre-market evaluation, post-market medical device surveillance and compliance for all radiation emitting medical devices. The division is also responsible for the regulation of radiation-emitting consumer products.Michael earned his Bachelor’s degree in biology from D’Youville College in Buffalo, a Master’s degree in Natural Sciences from the State University of New York at Buffalo and a Ph.D. in Biological Sciences from Wayne State University in Detroit. He completed a postdoctoral fellowship in the laboratory of Experimental Radiation Oncology at Thomas Jefferson University in Philadelphia and remained as a faculty member in the Department of Radiation Oncology. In 1996, he moved to Cordis, a Johnson and Johnson company to manage the firm’s vascular restenosis radiation therapy efforts. Michael joined the Food and Drug Administration in 2004 in the Division of Biology in the Office of Science and Engineering Laboratories within CDRH. His interests included relative biological effectiveness of ionizing radiation, radiation oncology and radiation biodosimetry.
Daniel Krainak is a biomedical engineer in the Division of Radiological Health in the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration. He participates in the review of premarket submissions, post market activities, and surveillance activities primarily related to radiological devices, with an emphasis on magnetic resonance imaging. Dan began his career at FDA through a one year postdoctoral fellowship under Sunder Rajan, Ph.D. at the Office of Science and Engineering Laboratories studying diffusion tensor imaging. Prior to that, Dan received a Bachelor in Biomedical Engineering from the Catholic University of America, Washington, D.C. and his M.S. and Ph.D. in biomedical engineering from Northwestern University. Dan’s current interests include validation of quantitative imaging biomarkers, MRI, MR safety, neuroimaging, liver imaging, and the use of radiological imaging in therapeutic product clinical trials. Dan’s interests may be expanded at any time.