QMSR / ISO 13485 §820.30(b)

QMSR / ISO 13485: §820.30(b)

ISO 13485: §7.3.2

Under old Part 820, section 820.30(b) required manufacturers to establish and maintain a design and development plan that described or referenced the design and development activities and identified responsibility for implementation. The regulation was relatively brief, leaving significant discretion to the manufacturer on how to structure planning documentation.

ISO 13485:2016 clause 7.3.2 is more prescriptive in several ways. First, it explicitly requires that planning output be documented and updated as the design progresses — not merely established at project start. The plan must address design and development stages, the review(s) needed at each stage, and the verification, validation, and design transfer activities appropriate to each stage. ISO 13485 also explicitly requires that responsibilities and authorities for design and development be defined, and that interfaces between different groups involved in design be managed to ensure effective communication and clear assignment of responsibility.

A key structural difference is the ISO 13485 requirement to plan for design transfer activities from the outset, rather than treating transfer as a separate downstream event. Part 820's planning requirement did not explicitly call out transfer planning. ISO 13485 also requires that planning be updated as the design evolves, creating a living document obligation rather than a static initial plan.

The FDA preamble to the QMSR final rule (February 2024) noted that this alignment with ISO 13485 planning requirements strengthens the expectation for ongoing plan maintenance. Companies whose design plans are created at project kickoff and never updated — a common pattern under Part 820 — will need to adopt a more dynamic approach to planning documentation.