Given the recent recalls of thousands of insecure medical devices, the FDA is now on record requiring that manufacturers assess security risks and maintain medical device functionality and safety through carefully chosen cybersecurity controls. Failure to do so can result in compromised device functionality, loss of data (medical or personal) availability or integrity, or exposure of other connected devices or networks to security threats. This in turn may have the potential to result in patient illness, injury, or death.
But even if you have created a secure medical device from a technical perspective, what does FDA’s new guidance around how you should assess and document your cybersecurity controls mean about the approval of your 510(k) submission? After all, if you don’t document it correctly, it means the FDA doesn’t think your device will be secure. Many medical device manufacturers, especially those that are new to the FDA submission process but even those that haven’t submitted a new device registration for some time, are caught off guard when their 510(k) submission is rejected due to lack of proper cybersecurity management content. As a device manufacturer, your product’s regulatory approval depends on good cybersecurity practices as well as superb documentation of those controls.
Does your team have the skills to choose a cybersecurity risk framework, conduct comprehensive assessments, implement cybersecurity standards, and document your infrastructure, threats, vulnerabilities, and incidence response plans specific to your medical device?
Get the Guidance for Industry and Food and Drug Administration Staff for Post Market Management of Cybersecurity in Medical Devices (PMMoC MD) and Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
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