FDA Cyber Device Guidance — Monitor and maintain the security of each device for the life of the device

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All authors
All authors

April 6, 2023

FDA Cyber Device Guidance — Monitor and maintain the security of each device for the life of the device

The recent FDA “cyber device” Refuse to Accept (RTA) guidance will be enforced starting October 1, 2023. This guidance indicates that manufacturers need to address cybersecurity throughout the product lifecycle, encompassing design and development, production, distribution, and postmarket cybersecurity management and maintenance of the device. The guidance specifically requires medical device manufacturers (MDMs) to submit a plan to monitor, identify, and address postmarket cybersecurity risks, including vulnerability disclosure and related procedures.

The impact of this guidance is significant, since most of the top device manufacturers either have a connected device on the market. Connectivity has become ubiquitous across devices with the intent to deliver better clinical outcomes for patients and providers. Device manufacturers, however, frequently struggle to dedicate adequate budget to securing these connected devices. This will be a significant change for many, but a much needed evolution to the way we approach device development and maintenance.

Further, security-capable pre- and post-market processes are a prerequisite to deliver more secure devices to the market and to make it easier to maintain the device’s security posture. With a proactive strategy, resources can be allocated and mistakes can be found before there is an issue. Ultimately, this can result in reduced security risks and overall lower cost associated with security.

Follow along this week as we break down how the guidance affects your organization. Register for the free webinar on April 11 at 10:30am PT/1:30pm ET to learn more from MedCrypt’s experts.

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