EU CRA, FDA, and Cyber Regulations
The regulatory landscape for product security has fundamentally shifted. What was once a “nice-to-have” consideration has become mandatory compliance across industries, with cybersecurity now sitting at the center of product development, risk management, and go-to-market strategies.
Product leaders today face mounting pressure from multiple regulations—the EU Cyber Resilience Act (CRA), FDA cybersecurity requirements, and a growing list of industry-specific mandates—while still needing to maintain innovation speed and profitability. The stakes couldn’t be higher: non-compliance risks include fines up to €15 million or 2.5% of global turnover under the CRA, market access restrictions, and potentially devastating reputational damage.
But here’s the critical insight that forward-thinking product leaders are discovering: these regulations don’t have to be a burden. When approached strategically, regulatory compliance can become a competitive differentiator that strengthens products, builds customer trust, and creates sustainable business advantages.
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The Product Compliance Tidal Wave: Understanding the Forces at Play
The 2024-2025 period has seen new cybersecurity regulations appear across sectors, representing a fundamental shift in how responsibility for product security is assigned and enforced.
The most significant change is the shift in liability. Under traditional models, end users often bore responsibility for securing the products they purchased. Today’s regulations flip this dynamic, making manufacturers the primary guardians of product security throughout the entire lifecycle. The CRA rebalances responsibility toward manufacturers and sets new standards across product lifecycles, fundamentally changing how companies must approach product development and support.
Supply chain transparency has become another critical factor. New requirements for Software Bills of Materials (SBOMs) and vulnerability disclosure mean that product leaders can no longer treat their supply chains as black boxes. Every component, every dependency, and every potential vulnerability must be catalogued, monitored, and managed.
As RunSafe Founder and CEO Joe Saunders has emphasized, “If a vendor can’t tell you what’s in their product, chances are, they don’t know either.” This lack of knowledge will no longer fly with consumers, regulators, or internal risk management teams.
Perhaps most importantly, these regulations demand a cultural transformation within organizations. As noted by cybersecurity experts at IMD Business School in a June 2025 Qt Group analysis, “the EU Cyber Resilience Act demands a fundamental cultural and leadership shift in organizations,” moving away from security as a bolt-on feature to security as a foundational element of product design.
The EU Cyber Resilience Act: A New Paradigm for Product Security
The CRA represents the most comprehensive product security regulation to date, with implications that extend far beyond European borders. Understanding its requirements isn’t just about compliance, it’s about understanding where the entire industry is heading.
Timeline and Strategic Implications
The CRA entered into force on December 10, 2024, but the most critical date for product leaders is December 11, 2027, when most obligations become enforceable. This timeline creates both urgency and opportunity: companies that start preparing now will have significant advantages over competitors who wait until the last minute.
The regulation’s scope is deliberately broad, covering all connected products and software sold in the EU, regardless of where the manufacturer is located. This means that any company selling digital products globally needs to consider CRA compliance as a baseline requirement.
Core Requirements That Change Everything
The CRA’s “Secure-by-Design” mandate isn’t just regulatory language but a complete shift in how products must be conceived, developed, and maintained. Security can no longer be retrofitted; it must be integral from the earliest design phases.
Vulnerability management under the CRA requires manufacturers to report vulnerabilities within 24 hours of discovery and implement coordinated disclosure processes. This creates new operational requirements but also opportunities for companies that excel at rapid response and transparent communication.
The documentation requirements are extensive, covering security documentation, risk assessments, and conformity declarations. While this creates an administrative burden, it also forces companies to develop more rigorous security practices that typically result in higher-quality, more resilient products.
Post-market obligations represent perhaps the biggest shift, requiring ongoing security updates for a minimum of five years or the expected product lifetime. This transforms the economics of product development, making long-term security support a core business consideration rather than an afterthought.
FDA Cybersecurity Requirements: Medical Devices Lead the Way
The FDA’s 2025 cybersecurity guidance updates represent a maturation of medical device security requirements, but their implications extend beyond healthcare. As one of the most regulated industries, medical devices often preview compliance approaches that eventually spread to other sectors.
The New Enforcement Reality
The FDA’s latest guidance mandates that cybersecurity must be demonstrated from pre-market design through post-market support, with strong documentation on vulnerabilities and supply chain transparency for all device components. This lifecycle approach mirrors the CRA’s philosophy and suggests a convergence toward comprehensive product security requirements across industries.
The emphasis on SBOM requirements for connected medical devices creates new transparency obligations but also opportunities for companies that can demonstrate superior supply chain security. Companies that proactively implement robust component tracking and vulnerability management will find themselves better positioned for both regulatory compliance and customer trust.
Strategic Impact on Product Development
The FDA’s approach changes go-to-market strategies for medical technology companies. Security documentation is now part of the regulatory submission process, meaning that security considerations must be built into product development timelines from the beginning.
This creates new resource allocation challenges, as companies need dedicated cybersecurity expertise within product teams. However, it also creates competitive advantages for companies that develop this expertise early and can demonstrate superior security practices to customers and regulators.
Learn more about navigating vulnerability identification and postmarket cybersecurity for medical devices in this video: On-Demand Webinar: Medical Device Cybersecurity Challenges
Strategic Focus Areas: Maximizing ROI on Security Investments
With limited resources and expanding regulatory requirements, product leaders must prioritize their security investments strategically. The most successful companies focus on areas that provide both regulatory compliance and business value.
Supply Chain Security and SBOM Management
SBOM requirements appear across multiple regulations—the CRA, FDA guidance, and emerging requirements in other sectors. This makes supply chain transparency a high-leverage investment that addresses multiple compliance requirements simultaneously.
The business case extends beyond compliance. Companies with comprehensive SBOM capabilities can respond faster to supply chain vulnerabilities, reduce incident response costs, and demonstrate superior risk management to customers and partners. The key is implementing automated SBOM generation and continuous component monitoring rather than treating it as a one-time documentation exercise.
Vulnerability Management Excellence
Both the CRA’s 24-hour reporting requirement and the FDA’s lifecycle security obligations demand sophisticated vulnerability management capabilities. Companies that excel in this area gain competitive advantages that extend far beyond compliance.
Proactive vulnerability management reduces breach costs significantly—studies show comprehensive vulnerability management programs can reduce incident costs by millions of dollars. Research indicates that the average cost of a data breach reached $4.88 million in 2024, according to IBM’s Cost of a Data Breach Report. More importantly, companies known for rapid, transparent vulnerability response build trust with customers and partners that translates into business growth.
The implementation challenge is building systems that can automatically detect, assess, and respond to vulnerabilities across complex product portfolios. This requires integration between threat intelligence, asset management, and incident response processes.
Secure Development as Competitive Advantage
The CRA’s Secure-by-Design requirements and the FDA’s lifecycle approach both emphasize building security into products from the ground up. Companies that master secure development practices don’t just achieve compliance—they build products that customers trust and competitors struggle to match.
Key elements include integrated threat modeling, secure coding standards, and security testing throughout the development lifecycle. The goal isn’t just to pass security audits but to build products that are inherently more resilient and trustworthy.
The Benefits of Proactive Product Compliance
The most successful product leaders are discovering that proactive product compliance creates business value that far exceeds the investment required.
Competitive Differentiation Through Security
In increasingly security-conscious markets, products with built-in security capabilities command premium pricing and win more procurement decisions. This trend is particularly pronounced in healthcare, where RunSafe Security’s 2025 Medical Device Cybersecurity Index found that 60% of healthcare organizations prioritize built-in cybersecurity protections when selecting vendors, with 79% willing to pay a premium for devices with advanced runtime protection.
Security-first product positioning also builds long-term customer relationships. Companies that can demonstrate transparent security practices and rapid vulnerability response develop customer loyalty that extends beyond individual product transactions.
Operational Excellence and Risk Reduction
Secure-by-Design development practices reduce technical debt by preventing security issues rather than retrofitting solutions. This approach typically results in lower long-term development and maintenance costs, even accounting for upfront security investments.
Good security practices also streamline regulatory audits and compliance verification. Companies with mature security programs spend less time and resources on compliance activities because their standard practices already meet or exceed regulatory requirements.
Financial Returns and Investment Attraction
The financial benefits of proactive security extend beyond cost reduction. Healthcare organizations demonstrate this market reality clearly, as seen in RunSafe’s 2025 Medical Device Cybersecurity Index. 79% of healthcare buyers are willing to pay a premium for devices with advanced runtime protection, with 41% willing to pay up to 15% more for enhanced security. Additionally, 83% of healthcare organizations now integrate cybersecurity standards directly into their RFPs, while 46% have declined to purchase medical devices due to cybersecurity concerns.
Risk reduction creates additional financial value through lower incident response costs, reduced legal exposure, and improved cyber insurance rates. Companies with strong security programs often achieve significantly lower insurance premiums and better coverage terms. The documented financial impact of attacks like WannaCry, which cost the NHS £92 million, demonstrates that prevention is far more cost-effective than recovery.
What’s Next: Preparing for the Evolving Landscape
The regulatory landscape will continue to evolve, with several emerging trends that product leaders should monitor and prepare for.
- AI and machine learning governance represent the next frontier of product regulation. As AI capabilities become embedded in more products, expect new requirements for AI security, transparency, and accountability.
- Quantum-safe cryptography is another emerging area. As quantum computing capabilities advance, current cryptographic standards will become vulnerable, creating new requirements for post-quantum security measures.
- Cross-border data flow regulations continue to evolve, with new privacy and data localization requirements affecting how products handle and store user data.
Strategic Recommendations for Product Leaders
Based on the regulatory trends and business opportunities outlined above, several strategic recommendations emerge for product leaders navigating this complex landscape:
1. Invest heavily in automation capabilities
Manual compliance processes are unsustainable given the complexity and pace of regulatory change. Companies that build automated compliance capabilities will have significant advantages over competitors still relying on manual processes for monitoring, reporting, and verification.
2. Build strategic security partnerships
Few companies have all the expertise needed to excel across the full spectrum of security and compliance requirements. Strategic partnerships with specialized security vendors can provide access to expertise and capabilities that would be expensive to develop internally while accelerating time-to-market for compliant products.
3. Focus on security solutions that eliminate entire vulnerability classes
Rather than playing defense against individual threats, prioritize technologies that can eliminate broad categories of vulnerabilities. Runtime protection solutions that prevent exploitation at the device level represent this approach—they provide comprehensive protection without requiring constant updates or patches. This strategy significantly reduces risk while simplifying compliance management across product portfolios.
4. Stay informed about regulatory developments through structured processes
The regulatory landscape continues to evolve rapidly, and companies that can anticipate changes rather than just react to them will maintain competitive advantages. Establish dedicated resources for monitoring regulatory trends and translating them into product development requirements.
5. Design for global compliance standards from the start
Rather than building separate compliance programs for different markets, design for the most stringent requirements across all target markets. This approach reduces complexity while ensuring products can be sold in any market without additional compliance engineering.
Product Compliance as a Competitive Advantage
The convergence of the EU Cyber Resilience Act, FDA cybersecurity requirements, and other emerging regulations represents both the greatest challenge and the greatest opportunity facing product leaders today. The companies that view these requirements as innovation drivers rather than compliance burdens will build more secure, resilient, and successful products.
The critical insight is that waiting is not a viable strategy. The December 2027 CRA deadline and evolving FDA requirements create urgency, but companies that start building security capabilities now will discover that the benefits extend far beyond regulatory compliance.
For product leaders ready to turn cybersecurity compliance into a competitive advantage, the path forward is clear: embrace security as a core product differentiator, invest in the capabilities needed to excel at both security and compliance, and build the partnerships needed to stay ahead. The companies that make these investments today will be the market leaders of tomorrow.
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