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The clauses behind the compliance.
Plain-language explainers for the standards and regulation clauses that govern regulated-hardware compliance — each tied to its primary source and the Forge analyses that apply it.
510(k)
ESPR
EU CRA
- Regulation (EU) 2024/2847 (Cyber Resilience Act) · Article 14 Reporting obligations for actively exploited vulnerabilities and severe incidents
- Regulation (EU) 2024/2847 (Cyber Resilience Act) · Article 32 Conformity assessment procedures for products with digital elements
- Regulation (EU) 2024/2847 (Cyber Resilience Act) · Article 64 Administrative fines and penalty tiers
EU Right to Repair
FDA 524B
- FD&C Act Section 524B · 524B(b)(3) Software bill of materials requirement
- FD&C Act Section 524B · 524B(c) Definition of a "cyber device"
- FDA Cybersecurity Premarket Guidance · 2025 final guidance — security architecture Security architecture views expected in a premarket submission
- FDA Refuse to Accept Policy (Section 524B) · RTA policy — effective 1 October 2023 Refuse to Accept enforcement for cyber device submissions