Guides for optional PCCP planning, applicable device-change assessment, and separate Section 524B cybersecurity duties.
PCCP mechanics
The three recommended components of the FDA's August 18, 2025 final AI PCCP guidance, with non-AI cybersecurity and firmware planning illustrations, not established coverage under that AI-specific final guidance.
Read the guideSBOM / VEX workflow
Monitor components, assess device-specific risk, and route changes through applicable quality and regulatory change control. VEX is optional; PCCP coverage and CAPA applicability are separate determinations.
Read the guidePathway differences
Decide whether a security-relevant modification belongs in a PCCP, a letter-to-file, or a new 510(k) / De Novo / PMA submission, with the pathway-by-pathway cybersecurity expectations reviewers apply.
Read the guidePostmarket monitoring
Section 524B(b)(1) monitoring and coordinated-disclosure plans, with separate (b)(2) cybersecurity and update processes. A PCCP is optional and only its authorized modifications are covered.
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30-minute scoping call. We map your patching cadence, SBOM refresh, and postmarket plan against the August 18, 2025 final AI PCCP guidance and applicable Section 524B duties. A PCCP is optional.
