June 21, 2023
In the fast-paced and ever-changing landscape of medical technology, staying compliant with regulations is critical. On March 29, 2023, the amendment to the Food, Drug & Cosmetic Act (FD&C), referred to as the “PATCH Act,” went into effect. The next day, the Food and Drug Administration (FDA) issued a new final guidance, revamping its Refuse to Accept (RTA) policy to consider a lack of cybersecurity documentation in the decision to refuse to accept submissions for new or modified medical devices. It was a move that signaled a significant shift in how Medical Device Manufacturers (MDMs) must approach cybersecurity in order to get products through FDA clearance or approval.
The FDA Cybersecurity RTA guidance, issued on March 30th, 2023, mandates MDMs shall submit to FDA a robust plan for addressing post-market vulnerabilities, a clear strategy for vulnerability disclosure, and a comprehensive software bill of materials (SBOM). This comes in line with section 524B of the FD&C Act which includes a requirement that a manufacturer shall “submit to the Secretary a plan to monitor, identify, and address, as appropriate, in a reasonable time, postmarket cybersecurity vulnerabilities and exploits, including coordinated vulnerability disclosure and related procedures.” Medcrypt’s Helm software enables a manufacturer to collect SBOM for all devices in their inventory, including multiple discrete versions of each device, in order to monitor vulnerabilities and possible exploits as they are identified and disclosed.
While the intention of FDA is to start refusing to accept submissions on the basis of cybersecurity only on October 1st, 2023, the FDA has already started issuing deficiency letters to MDMs regarding these cybersecurity documents, signaling the urgency and importance of compliance.
Navigating these new regulations can seem daunting. That’s why we developed Helm, MedCrypt’s SBOM and vulnerability management solution, designed explicitly with the MDM use cases in mind. Helm is more than just a tool; it’s a solution meticulously crafted to help MDMs not just meet but exceed the FDA’s cybersecurity guidelines.
Helm and MedCrypt services offer a host of features specifically designed to address the cybersecurity guidelines of the FDA:
MDMs have been using Helm over the past few years to stay ahead of their cybersecurity vulnerability management needs and maintain compliance with confidence.
The true measure of success, however, lies in the experience of our customers. In the upcoming months, we’ll share detailed case studies from customers who’ve harnessed the power of Helm to tackle their cybersecurity challenges head-on. You’ll get to hear first-hand accounts of how Helm has helped them remain compliant while also streamlining their processes and enhancing their product security.
At the end of the day, our goal is to ensure MDMs are equipped to navigate the rapidly evolving cybersecurity landscape confidently. With Helm, you can stay focused on what matters most — innovating and delivering high-quality medical devices, while we take care of your cybersecurity compliance needs.
Stay tuned for our upcoming customer case studies, and in the meantime, if you’re interested in learning more about how Helm can help your organization meet the FDA’s cybersecurity guidelines, request a demo by emailing info@medcrypt.com.
Helm is now available for medical device manufacturers Start a free trial of Helm today.
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