GLOSSARYGlobal

Design Review

A documented, systematic examination of a design at planned stages to evaluate whether it meets its requirements and to identify problems.

Where it is written: ISO 13485:2016 clause 7.3.5; definition as in 21 CFR 820.3(h) before February 2, 2026
Old rule: 21 CFR 820.3(h) and 820.30(e), in Part 820 before February 2, 2026
Also called: design and development review

Avoid This Mistake

Clause 7.3.5 asks for representatives of the functions concerned and other specialists. The FDA's final rule treats the clause as leaving flexibility on how independent review is done.

Related terms

Design Controls Design and Development File

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