Science and Engineering Laboratories: Updates from FDA/CDRH

Medical device regulatory science research, video presentations, AI/ML research programs, and more

If your email program has trouble displaying this email, view as a webpage. Discover how scientists and engineers in the Office of Science and Engineering Labs (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. Upcoming Events Funding Opportunities to Support Small Businesses in Developing Medical Device Development Tools: Webinar   The National Institutes of Health's (NIH's) National Cancer Institute (NCI) is collaborating with CDRH to support the small business community in developing innovative medical device development tools (MDDTs). Two NIH/NCI funding opportunities are currently available for small businesses: Quantitative Biomarkers as Medical Device Development Tools for Cancer Evaluation Datasets as Medical Device Development Tools for Testing Cancer Technologies On Tuesday, August 24, 2021, from 2:00-3:00 p.m. ET, NCI and CDRH are holding a joint informational webinar to discuss these funding opportunities, MDDT program requirements, and small business eligibility criteria. Register for the NCI webinar . MDIC Medical Extended Reality Device Workgroup The Medical Device Innovation Consortium (MDIC) is establishing a medical extended reality device workgroup to develop an augmented/virtual reality implementation roadmap identifying open regulatory science research questions and knowledge gaps to be addressed to facilitate the integration of medical extended reality devices into healthcare and accelerate device availability to patients. Examples of topics to be considered include: Identification of and consensus on standard terminology Validation of characterization methods and specifications for head-mounted displays and other accessories used in medical extended reality devices Identification of pertinent quality control activities Evaluation of clinical validation approaches Suggested best practices for assessment of user interactions with medical extended reality devices Understanding evidence needed to support public and private payer coverage/cost/coding More information about MDIC's workgroup is available at www.MDIC.org. Highlights from Recent Conferences Accelerating Medical Device Innovation with Regulatory Tools: REdI Conference Hear from Ed Margerrison, PhD, Director of CDRH's OSEL, from his presentation at the Regulatory Education for Industry (REdI) Annual Conference in July 2021. This presentation on Accelerating Medical Device Innovation with Regulatory Tools introduced the FDA's Catalog of Regulatory Science Tools to help assess new medical devices and provide helpful resources and tips for finding and using these tools that can assist with development and assessment of emerging medical technologies. For more information, please see the FDA's Catalog of Regulatory Science Tools to help assess new medical devices. Artificial Intelligence and Digital Diagnostics: MDIC Annual Forum The Medical Device Innovation Consortium (MDIC) Annual Public Forum, held in June 2021, brought together MDIC members and the broader medical device and diagnostics community to discuss current trends in regulatory science as well as highlight the development of innovative regulatory science tools. Ed Margerrison, Ph.D, Director of CDRH's Office of Science and Engineering Laboratories, spoke on the panel discussion on Artificial Intelligence powered cancer diagnostics: How regulatory science can re-shape digital diagnostics. . OSEL Program Highlights Artificial Intelligence and Machine Learning (AI/ML) Research Program The Artificial Intelligence and Machine Learning (AI/ML) research program leads regulatory science efforts to develop new tools that balance the potential benefits of AI/ML adoption with the risks of a limited assessment paradigm. These tools are aimed at accelerating innovation and facilitating the development, review, and continued assessment of safe and effective AI-enabled devices in this fast-changing area. Examples of these tools include methods to: Help move the focus of AI-based device developers from data collection to actual product development Better understand and report the clinical benefit of AI-enabled devices for a diverse patient population Help AI-enabled devices to evolve safely for the benefit of users and patients once they are on the market Browse OSEL's Research Program Areas. For more information about the AI/ML Research Program, email OSEL_AIML@fda.hhs.gov. 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 Office of Science and Engineering Laboratories (OSEL) has developed, with new tools added as they become available. We've recently added the following 9 new tools to the catalog: Assessing respiratory adverse effects to medical devices Device biokinetic modeling framework Ethylene oxide and polymeric materials: Medical device considerations for material selection Evaluation of One-way Valves for use in Medical Devices Ex vivo porcine indwelling device contamination model Flexural Stiffness of Medical Textiles Fluorescence microscopy protocol for detecting bacteria on devices High-resolution whole body pediatric numerical simulation model Tissue-equivalent model to assess role of endothelial cells in the generation of proinflammatory MGCs at device implant sites Browse the Catalog of Regulatory Science Tools. Innovation in Regulatory Science Grant Award The Burroughs Wellcome Fund (BWF) has announced the recipients of the latest round of the Innovation in Regulatory Science Awards, which provide grants to academic investigators developing new methodologies or innovative approaches in regulatory science. Along with a team from the University of Akron, FDA staff will be collaborating on the joint project: A screening tool for predicting  immune response to polymers designed for soft implantable devices. This joint project is part of CDRH's continued effort to support development of regulatory science tools to help assess new medical devices and ultimately to further our understanding of medical device materials and improve the safety of devices for patients. NSF/FDA Scholar-In-Residence at the FDA The National Science Foundation (NSF), through the Directorate for Engineering, the Directorate of Computer and Information Science and Engineering Division of Computer and Network Systems, and the Directorate for Mathematical and Physical Sciences Division of Materials Research, along with the FDA, have established the NSF/FDA Scholar-in-Residence Program at the FDA. This program comprises an interagency partnership for the investigation of scientific and engineering issues concerning emerging trends in medical device technology. This partnership is designed to enable investigators in science, engineering, and computer science to develop research collaborations within the intramural research environment at the FDA. This solicitation features three flexible mechanisms for support of research at the FDA: Principal Investigators Postdoctoral Researchers Graduate Students Read more about the NSF/FDA Scholar-In-Residence Program and Medical Device Regulatory Science Research Programs Conducted by OSEL to explore research collaborations. 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.   Read More

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