All terms
Quality & RiskQuality System
Complaint Handling
Process for receiving, evaluating, and responding to device complaints.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
Per 21 CFR 820.198, manufacturers must maintain procedures for receiving, reviewing, and evaluating complaints, with timely investigation and - when reportable - submission to FDA under 21 CFR Part 803.What this means in practice
Complaint handling is the entry point for the post-market feedback loop, feeding CAPA, vigilance, and risk management updates.Cross-references
Precedes
Comes before in a typical workflow or lifecycle.
Primary references
3 sourcesLink health: 2 verified 1 needs review· last checked 2026-05-09
eCFR·1MDIC·1FDA·1
- 1
21 CFR 820.198Needs revieweCFRecfr.gov
- 2
MDIC Case for QualityVerifiedMDICmdic.org
- 3
FDA - Quality SystemsVerifiedFDAfda.gov
Inline markers like [1] jump to the matching reference above.