Pre-QMSR Part 820 §820.120

Pre-QMSR Part 820: §820.120 Device labeling.

ISO 13485: §7.5.1 Control of production and service provision

FDA QMSR (2026): §820.45 Device labeling and packaging controls.

Labeling errors are among the most frequently cited causes of device recalls because the label is the primary communication channel between the manufacturer and the user: incorrect identification, missing contraindications, erroneous instructions for use, or wrong-device labels on finished goods can cause patient harm directly — by directing the wrong device to the wrong use or by failing to convey the information a clinician needs to use the device safely. Label accuracy verification before release is the last gate before an incorrectly labeled device reaches a customer, and its effectiveness depends entirely on the verification being objective and documented rather than assumed. Label storage and issuance controls prevent mixing of label revisions and device types: mislabeled inventory is typically a storage and control problem, not a design problem — the correct label exists, but access to obsolete or mismatched labels was not controlled. UDI labeling requirements under the FDA UDI rule and QMSR 820.45 are regulatory requirements independent of the QMS procedure — the UDI must appear on the label in both human-readable and automatic identification and data capture (AIDC) format, and each label configuration must be registered in GUDID — making UDI label accuracy a regulatory compliance question, not merely a quality preference. Labeling procedures that are documented, trained, and verified create a consistent, auditable process that survives personnel turnover and reduces reliance on individual memory for a function where error consequences are immediate and visible.

Part 820 addressed labeling in section 820.120 (with device packaging under section 820.130): procedures to control labeling activities, label integrity (printed and applied so as to remain legible and affixed under customary processing, storage, handling, distribution, and use conditions), labeling inspection for accuracy before release by a designated individual, controlled labeling storage, and control of labeling operations to prevent mixups. These requirements were among the most prescriptive in Part 820.

ISO 13485:2016 does not have a dedicated labeling clause. Labeling is addressed only generally under clause 7.5.1 (control of production and service provision) which requires documented procedures and work instructions, and clause 7.5.8 (identification). There is no ISO 13485 equivalent to Part 820's explicit requirements for label inspection, label storage controls, or label issuance accountability.

This is a critical QMSR-specific retention. FDA agreed that ISO 13485 'does not specifically address the inspection of labeling by the manufacturer' and stated it is 'retaining in this rule requirements from the QS regulation that strengthen controls for labeling and packaging operations,' noting that many device recalls are related to labeling and packaging (preamble, Response to Comment 60, 89 FR 7515). The former §820.120 controls were carried into the new standalone §820.45 — strengthened but not verbatim: the codified text drops the named 'designated individual(s)' (the preamble still expects a designated individual to examine at minimum a representative sampling of labels checked by automated readers), drops 'control number' from the accuracy-check list, documents release per ISO 13485 Clause 4.2.5 instead of the DHR, and 'immediately before use' was removed in response to Comment 62. Additionally, the QMSR 820.45 requirement now encompasses UDI (Unique Device Identification) labeling requirements, linking labeling controls to the FDA UDI rule (21 CFR Part 830). This means FDA-regulated manufacturers must maintain labeling controls that exceed what an ISO 13485-only certification would require.