FDA Releases Draft Cybersecurity Guidance

The FDA has just released a new cybersecurity draft titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability.” The draft guidance can be viewed here. Comments are due July 7, 2022. 

What is the FDA proposing? 

In 2018, the FDA proposed updates to the final guidance, ‘‘Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,’’ and issued a draft guidance of the same name.”

This draft guidance replaces the aforementioned 2018 guidance and is “intended to further emphasize the importance of ensuring that devices are designed securely, are designed to be capable of mitigating emerging cybersecurity risks throughout the Total Product Life Cycle, and to clearly outline FDA’s recommendations for premarket submission content to address cybersecurity concerns.” 

Why is the FDA doing this? 

According to the draft guidance as “more medical devices are becoming interconnected, cybersecurity threats have become more numerous, more frequent, more severe, and more clinically impactful. As a result, ensuring medical device safety and effectiveness includes adequate medical device cybersecurity, as well as its security as part of the larger system.”

How Lanton Law can help

Society’s reliance on technology has become even more vital with the effects of COVID-19. With all of the hacking and malware attacks we have witnessed against various data stakeholders, we foresee cybersecurity as a major legal & policy area that will continue to be expanded.   

Lanton Law is a national boutique law and lobbying firm that focuses on technology and healthcare. If you are a tech or healthIT industry stakeholder with questions about the current landscape or if you would like to discuss how your organization’s strategic initiatives might be impacted by either Congress, regulatory agencies or legal decisions, contact us today.