With the February 2, 2026, implementation date for FDA’s Quality Management System Regulation (QMSR) quickly approaching, FDA has now issued a final rule making 179 technical amendments across Title 21 of the Code of Federal Regulations. These updates formally replace legacy Quality System Regulation (QSR) references with QMSR terminology throughout FDA’s medical device regulations.

While the rule is explicitly non-substantive and editorial in nature, it represents an important milestone in FDA’s transition away from QSR and toward a modernized, internationally harmonized quality framework aligned with ISO 13485:2016.

What Did FDA Do?

FDA amended 179 sections across 18 CFR parts, including labeling, medical device reporting, IDEs, classification procedures, and numerous device-specific regulations. The primary objective was consistency: ensuring that all references throughout FDA’s regulations accurately point to the QMSR framework that becomes effective February 2, 2026.

Key changes include:

• Replacing references to QSR (21 CFR Part 820) with QMSR where applicable
• Updating citations from §820.180 and §820.198 (QSR records and complaints) to the QMSR equivalent §820.35 (Control of Records)
• Aligning design control references to §820.10(c) (design and development under QMSR)
• Updating terminology from “quality system regulation” to “quality management system regulation”
• Correcting minor typographical and authority citation issues

Importantly, FDA confirmed these changes do not introduce any new regulatory requirements. They are strictly technical and editorial, intended to avoid confusion as the QMSR takes effect.

Why This Matters

Although these amendments are non-substantive, they send a clear signal: QMSR is no longer theoretical: it is operational.

Starting February 2, 2026:

• FDA inspections, enforcement language, and regulatory references will be rooted in QMSR terminology
• Legacy QSR language will no longer align cleanly with the CFR
• Internal SOPs, quality manuals, training materials, and regulatory documentation that still reference QSR may feel increasingly outdated or inconsistent with FDA language

For many organizations, especially those that delayed transition planning, this is a reminder that alignment is no longer optional.

Common Pitfalls We’re Seeing

In working with medical device companies preparing for QMSR, we frequently see:

• SOPs and quality manuals still structured entirely around QSR clause numbering
• Complaint handling and record-keeping procedures not clearly mapped to §820.35
• Design and development documentation that does not reflect QMSR language or structure
• Training materials that reference QSR terminology, creating internal confusion ahead of inspections

These issues don’t necessarily indicate noncompliance today, but they increase risk as the regulatory language shifts.

What Companies Should Be Doing Now

With the final technical amendments published, now is the right time to:

• Perform a QSR-to-QMSR gap assessment
• Update regulatory references in SOPs, templates, and quality documentation
• Confirm complaint handling, record controls, and design documentation align with QMSR expectations
• Train teams on QMSR terminology and structural changes before inspectors start using it exclusively

The transition to QMSR is happening now. The companies that prepare early will be the ones best positioned when FDA inspections catch up.

At Quality Solutions Now (QSN), we’re actively supporting clients with QMSR readiness, including gap assessments, SOP updates, documentation mapping, and practical transition strategies that fit real-world operations – not just regulatory theory.

If you’d like to discuss where your organization stands or how to prepare efficiently before February 2, 2026, please contact us now.