GLOSSARYUSGlobal

Design Controls Legacy term

The Quality System Regulation's requirements for controlling a device's design, from planning through design transfer. Records were kept in the design history file. Part 820 now meets the same need through ISO 13485 clause 7.3.

Replaced by: Design and development, ISO 13485:2016 clause 7.3 and its subclauses, applied through 21 CFR 820.10(c)
Where the replacement is written: 21 CFR 820.10(c); ISO 13485:2016 clause 7.3
Old rule: 21 CFR 820.30, in Part 820 before February 2, 2026
Also called: design and development

Avoid This Mistake

The current Part 820 has no section called design controls: 21 CFR 820.10(c) points to clause 7.3 and its subclauses.

All Terms Run the Design Controls & V&V Completeness Diagnostic

Design Controls Legacy term

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