Two CMTI teams place 2nd and 3rd in University's Regulatory Science Competition
Two teams of CMTI (Center for Medical Technology & Innovation) master’s students placed well in the University’s annual “America’s Got Regulatory Science Talent” competition, a UR CTSO Regulatory Science Program. Students are asked to find solutions to better assess the safety, efficacy, quality, and performance of FDA-regulated products. Eric Ravinal, Justin Schumacher, Vladimir Tokarchuk, and Rebecca Amorese finished second with their proposal for an evaluation toolkit to address key issues in additive manufacturing, including 3D printing. Amanda Smith, Meghann Meyer, Emily Newman, and Evan Sosnow proposed an FDA ALERT smartphone-based mobile app that could be used to scan a QR code on the label of an FDA-regulated product to get reliable, FDA-approved information to help them decide whether to purchase the product, to receive recall and warning alerts, and to report any adverse effects they’ve experienced with FDA-regulated products. The team finished third. Read more here.
Rochester Regulators: Ensuring FDA’s Readiness to Evaluate Additive Manufacturing
Eric Ravinal, Justin Schumacher, Vladimir Tokarchuk, Rebecca Amorese
Additive manufacturing, including 3D printing, is an emerging medical technology for creating drugs and devices. Limited guidance exists to evaluate this evolving technology and many factors influence the performance and quality of printed products. We propose an evaluation toolkit to address key issues in additive manufacturing. The toolkit would provide quantitative imaging biomarkers and real-time monitoring to identify printing defects, while quantifying realistic printer performance, resolution metrics, and material property integrity. This would help evaluate emerging technologies going through FDA review by assessing the build and post-processing validation steps in the FDA Guidance document.
FDA ALERT: Approved Listings & Explanations of Regulated Technology
Amanda Smith, Meghann Meyer, Emily Newman, Evan Sosnow
FDA ALERT is a smartphone-based mobile app that streamlines the process of accessing and reporting warnings, complications, and recalls associated with FDA-regulated products. Through the app, users are able to scan a QR code on the label of an FDA-regulated product to get reliable, FDA-approved, information to help them decide whether or not to purchase the product. FDA ALERT allows users to subscribe to the products they have purchased and receive recall and warning alerts on their phone in real time. The app also enables users to report any adverse effects they've experienced with FDA-regulated products through this portal.