Overview
The recent discussion among experts at the Medtech conference, highlighted by the FDA, underscores the critical importance of the Software Bill of Materials (SBOM) in medical device cybersecurity. Although SBOM generation tools are still in their early stages, the consensus is clear: manufacturers must start working immediately on assembling these documents. The SBOM is now an essential regulatory requirement for “cyber devices” and crucial for managing risks and ensuring patient safety. Experts emphasize the need for simplification, the inclusion of key partners in the process, and attention to the details of the human-readable format, which complements the machine-readable format required by the FDA.
Introduction
In an increasingly connected world, the safety of medical devices is paramount. The U.S. Food and Drug Administration (FDA) has strengthened its cybersecurity guidelines, making the provision of a Software Bill of Materials (SBOM) a mandatory component for premarket submissions of “cyber devices.”
The SBOM acts as a software ingredients list, detailing all third-party, open-source, or off-the-shelf software components used in a device. This transparency is vital for identifying and managing vulnerabilities proactively.
Recently, industry and regulatory experts met to discuss the challenges and best practices in assembling SBOMs. The core message? It’s time to act. This GRP post details the crucial recommendations and what your organization needs to know.
The Experts' Tips
The expert panel acknowledged that, while tools are available for automation, SBOM creation still faces challenges regarding tool maturity and initial data quality. However, the following tips were emphasized for manufacturers:
- Immediate Action (Just Start Doing It): The unanimous advice is that manufacturers should not wait for the “perfect” tool. The key is to initiate the SBOM generation process now.
- Even if the first draft might look “ugly,” starting ensures the organization is in motion toward compliance and learning.
- Simplification as a Security Guide: Fewer software components result in a cleaner SBOM and, consequently, one that is easier to manage and secure. Codebase simplification should be a guiding principle in secure product development.
- Risk Prioritization and Intended Use: While the machine-readable format (like SPDX or CycloneDX) is relatively simple to generate with tools, the human-readable format required by the FDA contains detailed fields. Manufacturers must carefully weigh the risks of thousands of components in relation to the device’s intended use to fill these fields meaningfully.
- Partner Integration: It is crucial to involve key partners in the development of the SBOM, ensuring that the information is accurate and that security processes extend throughout the supply chain.
- The SBOM as a “Living” Document: The SBOM is not a static document. It must be continuously maintained and updated to reflect software changes throughout the device lifecycle, which is essential for post-market vulnerability management.
Aspects of Impact of This News
The FDA’s focus on the SBOM, reinforced by the experts’ tips, has a multifaceted impact:
- Rigorous Regulatory Compliance: The SBOM is now a sine qua non requirement for the approval of new “cyber devices.” Non-compliance can result in delays or refusal of regulatory approval, impacting time-to-market.
- Proactive Risk Management: The SBOM transforms risk management from reactive to proactive. By knowing all components, manufacturers can quickly identify which devices are affected by a new vulnerability (like Log4j) and issue fixes or mitigations with agility, minimizing patient risk.
- Patient Safety: Cybersecurity in medical devices is intrinsically linked to patient safety. An accurate SBOM allows manufacturers and hospitals to act swiftly against threats that could compromise device functionality or patient data access.
- Increased Transparency: The requirement fosters a culture of greater transparency in the software supply chain, pressuring suppliers to provide SBOM information.
Conclusion
For GRP and all medical device manufacturers, the message from the FDA and the experts is unmistakable: the future of regulatory cybersecurity is transparent, and it begins with the SBOM.
While the path to a mature and perfectly automated SBOM may be long, immediate action is the only viable option. GRP is here to guide your team in transforming this regulatory challenge into a strategic advantage.
Our consultancy can help you:
- Design Your SBOM Strategy: Select the appropriate tools and formats (SPDX/CycloneDX) to start generating your SBOMs, even in an initial stage.
- Integrate SBOM into Your Product Lifecycle (SDLC/PLC): Ensure that SBOM generation and maintenance are continuous processes, not a one-time project.
- Ensure Regulatory Compliance: Verify that your SBOMs meet all FDA requirements, both in machine-readable and human-readable formats, which are essential for premarket submissions.
Don’t wait until the next critical vulnerability catches you off guard. Start building the transparency and resilience of your devices today. Contact GRP to protect your products, your patients, and your regulatory compliance.
GRP can act as your local Agent & Register your product in U.S
Contact our team today to Inquire!
Email: info@globalregulatorypartners.com
Telephone : (+1) 781-672-4200
References
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About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.