Quality & Risk
Complaint Handling
In one line
Process for receiving, evaluating, and responding to device complaints.
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.
A complaint is any communication alleging deficiencies in identity, quality, durability, reliability, usability, safety, effectiveness or performance of a device after release. Each one must be evaluated for whether it is a reportable event, investigated unless a documented rationale says otherwise, and trended. Under the QMSR, complaint requirements sit in ISO 13485 clause 8.2.2 plus FDA-specific record content kept in 21 CFR 820.35.
Why it matters
Complaint handling is the entry point for the post-market feedback loop, feeding CAPA, vigilance, and risk management updates.
Common pitfalls
- •Failure to define clear criteria for what constitutes a complaint can lead to underreporting or misclassification.
- •Inadequate investigation of complaints can result in recurring issues and potential harm to patients.
- •Delay in reporting reportable events to regulatory authorities can lead to severe non-compliance penalties.
- •Treating complaints solely as customer service issues rather than critical quality data can prevent effective corrective actions.
- •Insufficient documentation of complaint investigations and resolutions can lead to audit findings and regulatory scrutiny.
Sources
- 21 CFR 820.198 · eCFR
- MDIC Case for Quality · MDIC
- FDA - Quality Systems · FDA