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The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is announcing an interactive, in-person workshop entitled “Partnering with Patients on CDRH’s Research Agenda for Assistive and/or Neurostimulation Devices” The purpose of this workshop is to receive feedback on patient needs and experience regarding the usability, benefits, and desired features of medical…

What is Medical Device Interoperability? Medical device interoperability is the ability to safely, securely, and effectively exchange and use information among one or more devices, products, technologies, or systems. This exchanged information can be used in a variety of ways including display, store, interpret, analyze, and automatically act on or control another product. As electronic…

On Monday, July 11, 2016, the FDA will host a webinar to share information and answer questions about its draft guidance entitled ‘Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.’ This draft guidance released on June 15, 2016, focuses on the factors the FDA may consider when making decisions…

On February 26, 2016, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention’s (CDC) Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay (Zika MAC-ELISA) for the presumptive detection of Zika virus-specific IgM in human sera or cerebrospinal fluid (CSF) that is submitted alongside…

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The FDA is building the foundations of a national evaluation system to generate better evidence more efficiently for medical device evaluation and regulatory decision-making. A national evaluation system would generate evidence across the total product lifecycle of medical devices by strategically and systematically leveraging real-world evidence, and applying advanced analytics to data tailored to the…

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The Food and Drug Administration (FDA) is announcing a public Workshop entitled “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers.” The topics to be discussed are the current regulatory environment for these activities, the definitions of the various terms FDA proposed in our prior Federal…