Design Change

A change to a device's design after the design inputs are set. The change must be identified, reviewed, and approved before implementation. Verification and validation apply as appropriate.

Where it is written

ISO 13485:2016 clause 7.3.9

Old rule

21 CFR 820.30(i), in Part 820 before February 2, 2026

Also called

design and development changes

Related terms

On this site

• Design Change Routes: 510(k), PMA Supplement, or Documentation