Documented plan identifying stages, responsibilities, and design activities — structure from 820.30(b) survives intact.
Plan must be updated as design progresses; interface management between groups and transfer activities required from outset.
Plan revision history and dated update records — common gap area for legacy static DHF plans.
Maps to
QMSR / ISO 13485: §820.30(b) Design and development planning.
ISO 13485: §7.3.2 Design and development planning
ISO 14971: §4.4 Risk management plan
Requirement text
The organization shall document design and development planning. As development progresses, planning shall be documented and updated as appropriate.
Why this clause exists
Design projects that begin without a written plan predictably fail to allocate adequate resources for verification, validation, and transfer activities — the stages where regulatory evidence is created. Under the legacy Part 820.30(b) regime, many manufacturers produced a one-page plan at project kickoff, signed it, and filed it in the Design History File without ever updating it. When the design later changed direction, the plan became fiction, leaving auditors no way to evaluate whether reviews, verification, and validation occurred at the stages originally committed to. ISO 13485 clause 7.3.2 — incorporated into the QMSR at 820.10 — requires that planning be treated as a living document: updated as the design progresses, structured to identify stages, review events, verification and validation activities per stage, responsibilities, traceability methods, and competence requirements. The regulator's interest is traceability: if the plan commits to a design review at the prototype stage and the record shows no review at that stage, either the plan was wrong or the event was skipped. Both outcomes indicate a breakdown in disciplined development. For FDA, a QMSR inspection of design controls begins with the design plan; inspectors use it to navigate to the evidence they expect to find.
What changed
§820.30(b) — Part 820 (legacy)
"Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves."
§7.3.2 — ISO 13485:2016 (current)
"The organization shall plan and control the design and development of product. As appropriate, design and development planning documents shall be maintained and updated as the design and development progresses. During design and development planning, the organization shall document: a) the design and development stages; b) the review(s) needed at each design and development stage; c) the verification, validation, and design transfer activities that are appropriate at each design and development stage; d) the responsibilities and authorities for design and development; e) the methods to ensure traceability of design and development outputs to design and development inputs; f) the resources needed, including necessary competence of personnel."
Δ Adds documented design stages, traceability methods, and competence/resource planning per stage; V&V and transfer activities now sit on the planning surface.
Common gaps (what we see in audits)
- Static design plan never updated after initial approval — Many Part 820-era design plans are created at project initiation and archived. ISO 13485 7.3.2 explicitly requires that planning documentation be updated as the design and development progresses, reflecting changes in scope, timeline, resources, and activities.
- Missing interface management between groups — ISO 13485 7.3.2 requires that interfaces between different groups involved in design and development be managed to ensure effective communication and clear assignment of responsibility. Many legacy QMS plans identify team members but do not define how cross-functional interfaces (e.g., between R&D, manufacturing, quality, regulatory) are managed.
- Design transfer not addressed in planning stage — ISO 13485 requires that design transfer activities be planned from the outset as part of the design and development plan. Many Part 820-era plans do not mention transfer until the project is nearing completion, creating gaps in resource allocation and timeline planning for manufacturing readiness.
- Static design plans — Design plans are treated as one-time documents rather than 'living' documents that are updated as the project evolves. ISO 13485 §7.3.2 requires plans to be updated as appropriate during the design and development process.
- Missing transfer activity definitions — The design plan fails to define specific activities needed for the transfer of design to production. ISO 13485 requires 'design transfer activities' to be part of the plan.