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What actions should you take if the change is made solely to strengthen cybersecurity and does not have any other impact on the software or device?

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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

In many cases, a change made solely to strengthen cybersecurity is not likely to require submission of a new 510(k). Cybersecurity updates are considered a subset of software changes that are implemented to strengthen the security of a system, protect information, and reduce disruption in service. FDA expects manufacturers to ensure that such changes do not impact the safety or effectiveness of the device by performing necessary analysis, verification, and/or validation. The manufacturer should refer to FDA’s guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices and Postmarket Management of Cybersecurity in Medical Devices for more information.

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