Healthcare IT News March 15, 2024
The agency further defines when it considers a device to be Internet-enabled, proposes to add vulnerability disclosures, and makes recommendations for cyber device maintenance plans and patch timelines.
The U.S. Food & Drug Administration issued select updates to premarket cybersecurity guidance including who is required to comply, the types of devices that fall under certain agency requirements and recommendations on how to document related compliance in premarket submissions.
WHY IT MATTERS
FDA said in theFederal Register Wednesday that the proposed update to its final “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” “considers the ‘ability to connect to the Internet’ to include devices that can connect whether intentionally or unintentionally, through any means – including at...
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