• Regulatory NewsRegulatory News

    UL Wades into Cybersecurity of Connected Medical Devices

    Safety science firm UL is honing in on the cybersecurity of connected medical devices, suggesting a two-pronged approach that spans across the total product life cycles of devices and the healthcare ecosystem.   UL began wading into healthcare as it increasingly became a prime target for cyber attacks in recent years, Anura Fernando, UL chief innovation architect of medical systems interoperability and security, told Focus . Factors that drove its decision to join the...
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    ICMRA Looks to Make Track-and-Trace Systems Globally Interoperable

    The International Coalition of Medicines Regulatory Authorities (ICMRA) has its eye on aligning existing and planned track and trace systems worldwide, with a focus on interoperability as many of the existing and planned systems were designed with a national or regional focus. Track and trace systems, which have been or are currently being implemented in the US, EU, Turkey, Argentina, Canada, Italy and Japan, are used to help ensure falsified, counterfeit or otherwi...
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    Interoperable Medical Devices: FDA Offers Design, Labeling Considerations

    With an eye on helping medical device manufacturers ensure their products can safely and effectively exchange data, the US Food and Drug Administration (FDA) on Monday released new draft guidance on how to design such interoperable devices, as well as recommendations for labeling. The advance of interconnected devices could be a boon for patient care, particularly in cases where device-specific information, such as unique device identifiers (UDIs), and patient-specific d...