All terms
Quality & RiskQuality System
Servicing (21 CFR 820.200)
Quality system requirements for servicing devices, including service report analysis as potential complaints.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
Manufacturers performing service activities must document procedures, maintain records, and treat reports of events meeting MDR criteria as complaints. FDA has historically scrutinized 'right to service' between OEMs and third-party servicers.What this means in practice
Active area of policy discussion - FDA has held public meetings on third-party servicing and parts availability.Primary references
3 sourcesLink health: 3 verified· last checked 2026-05-09
eCFR·1AAMI·1MDIC·1
- 1
21 CFR 820.200VerifiedeCFRecfr.gov
- 2
AAMI - Quality Systems ResourcesVerifiedAAMIaami.org
- 3
MDIC Case for QualityVerifiedMDICmdic.org
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