FDA's Public Meeting on Cybersecurity Content in Premarket Submissions: ECRI Institute's Perspectives

February 8, 2019 | Evaluations & Guidance


As the focus of the #1 hazard on our list of the Top 10 Health Technology Hazards for 2019, medical device cybersecurity is a topic that the healthcare industry pays very close attention to—particularly when developments occur that could affect healthcare providers. One such development occurred in January 2019, when FDA held a public workshop that brought together many stakeholders, including ECRI Institute, to discuss cybersecurity of medical devices.

The main purpose of the meeting was to allow the stakeholders to share their opinions and experiences with FDA as the agency works toward finalizing a draft guidance document that revises the cybersecurity-related information medical device manufacturers will be asked to provide when submitting a premarket notification (i.e., a 510k) to FDA for their devices. The draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, was published in October 2018 and will supersede the current FDA guidance, published in 2014. A [docket is open for...

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