AI Assurance DirectoryIEC 62304 and FDA PCCP — two ways of talking about changes to AI device software
Informational only, not professional or legal advice. Facts are linked to the source we checked; statuses can change after the date above.
The IEC catalog describes IEC 62304:2006 as defining the life cycle requirements for medical device software. A consolidated version, IEC 62304:2006+AMD1:2015 CSV, combines the first edition (2006) with its amendment 1 (2015). The catalog page for the consolidated version does not describe what the amendment changed, so this article does not either.
The PCCP guidance recommends that a plan describe planned device modifications, the methodology to develop, validate and implement them, and an assessment of their impact. FDA reviews the PCCP as part of a marketing submission.
Editorial judgment: One standard organizes the software life cycle; the other asks a manufacturer to say in advance which modifications it plans. For an AI-enabled function, the useful bridge question is whether each modification type in the PCCP maps to a documented life-cycle activity (change request, verification, release) in the manufacturer’s software process. Neither official page states such a mapping; this is an analyst framing. Listings: Aligned Elements names pre-defined IEC 62304 Design Control templates, and ENVOLOK checks a modification against an FDA-authorized PCCP.