Complaint Handling
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.What this means in practice
Complaint handling is the entry point for the post-market feedback loop, feeding CAPA, vigilance, and risk management updates.Examples
- A medical device manufacturer receives a report from a hospital indicating that a surgical instrument malfunctioned during a procedure, requiring a procedure to be restarted.
- A patient contacts a MedTech company via their website to report an unexpected side effect experienced after using a new diagnostic device.
- An internal quality control team identifies a trend of similar issues across multiple devices during routine complaint review, prompting a broader investigation.
- •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.
Frequently asked questions
Cross-references
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsSystematic process to investigate and resolve quality issues and prevent recurrence.
FDA mechanism for receiving reports of device-related deaths, serious injuries, and malfunctions.
Reporting and management of serious incidents and field safety corrective actions.
QMS Foundations
· From this learning pathNotice of inspectional observations issued at the conclusion of an FDA inspection.
Structured process governing the design of medical devices.
Compilation of records describing the design history of a finished device.
FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference.
Post-Market Mastery
· From this learning pathAction taken to reduce a risk of serious deterioration in health associated with a device.
Removal or correction of a marketed device that violates FDA law.
Periodic EU MDR/IVDR report summarizing post-market surveillance findings.
Activities to monitor device safety and performance after market release.
Where this term appears across MedTech Terms.
- QMS FoundationsLesson 8 of 10
- Post-Market MasteryLesson 7 of 9
Latest in MedTech
Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 121 CFR 820.198Tier 1 VerifiedeCFRecfr.gov
- 2MDIC Case for QualityTier 4 VerifiedMDICmdic.org
- 3FDA - Quality SystemsTier 2 VerifiedFDAfda.gov
Inline markers like [1] jump to the matching reference above.