21 CFR 820.30 - Design Controls (QMSR)

What it says

Manufacturers of certain medical devices must establish and maintain procedures for design control, including design planning, input requirements, output specifications, review, verification, validation, transfer to production, and a design history file documenting the design process for each device type.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Design controls apply across the full development lifecycle, from initial design input through to production transfer, with each stage requiring documented evidence rather than the design history file being assembled retrospectively.
• Design verification, confirming design output meets design input requirements, is distinct from design validation, confirming the finished device meets user needs and intended use, and both are required as separate, documented activities.
• Design transfer to production is a formal, controlled step, not an informal handoff, requiring documented evidence that design output was correctly translated into production specifications.

What FDA inspectors look for

• Whether the design history file provides a genuinely traceable record connecting design input, output, verification and validation for a specific device, rather than disconnected fragments.
• Whether design verification and design validation are clearly distinguished as separate activities with separate documented evidence, rather than conflated into one another.
• Whether design changes after initial development went through the same documented design control rigor as the original design.

Related regulations