FDA's QMSR Places New Emphasis on Device Design Changes: Analysis

A new analysis published in Machine Design examines how medical device manufacturers must ensure that engineering design changes are reflected accurately in production records under FDA's Quality Management System Regulation (QMSR).

The QMSR, which took effect February 2, 2026, incorporates ISO 13485:2016 into 21 CFR Part 820 and changes how manufacturers document design revisions, production activities and device traceability.

Celeste Lefebvre, product manager at Eyelit Technologies, says in her authored analysis that manufacturers must be able to establish which design revision was used for each device or batch, identify the materials and components involved, and document inspection results and approvals.

Although the QMSR eliminates the former regulatory definition of the device history record, ISO 13485 continues to require production records for individual devices or batches. FDA's revised regulation also retains additional recordkeeping requirements, including unique device identification information.

The analysis emphasizes that engineering change orders must identify when revisions become effective, which manufacturing documents are affected and how changes are communicated to production personnel. Under ISO 13485, design changes must be reviewed, verified, validated where appropriate and approved before implementation.

Manufacturers must also evaluate whether changes to previously cleared devices require a new 510(k) submission, rather than relying solely on internal classifications of changes as major or minor.

Electronic production records and signatures may trigger additional requirements under 21 CFR Part 11, including controls governing authorization, signature identification and record integrity.

Lefebvre also recommends establishing component-level traceability early in device development and maintaining separate records for experimental production runs to prevent unapproved revisions from entering commercial distribution.

The analysis underscores the importance of integrating engineering, quality assurance and manufacturing systems to demonstrate compliance during FDA inspections.