February 2, 2026. This date marks a regulatory milestone that will reshape how medical device manufacturers approach quality management, documentation, and design controls. The FDA's new Quality Management System Regulation (QMSR) replaces the 21 CFR 820 Quality System Regulation that has governed the industry for decades.
Understanding these changes isn't optional. It's essential.
The QMSR amends 21 CFR Part 820 and incorporates ISO 13485:2016 by reference. This is significant because it represents the first time FDA regulation directly aligns with the international medical device quality standard.
The regulatory structure itself changes dramatically. The previous framework was spread across 15 subparts. The QMSR consolidates these into Subparts A and B, with Subparts C through O reserved. While this appears cleaner on paper, the consolidation doesn't mean simplification.
The FDA has established additional clarifications and requirements to ensure that incorporating ISO 13485 doesn't create inconsistencies with FDA-specific mandates like Medical Device Reporting (MDR) and Unique Device Identification (UDI). These FDA-specific requirements remain—and are now more explicitly defined.
Under the previous QS regulation, certain quality management activities were exempt from FDA inspection. Management reviews, quality audits, and supplier audit reports fell into protected categories.
This changes under QMSR.
The FDA now has direct authority to inspect management reviews, quality audits, and supplier audit reports. Your entire quality management system becomes auditable. This expanded inspection authority means manufacturers must ensure these previously protected processes meet the same documentation rigor and compliance standards as other regulated activities.
QMSR explicitly requires control of complaint records, servicing activities, and integration of Unique Device Identifier (UDI) information into all relevant records. Traceability requirements are now more defined.
What this means: Your complaint handling system, your service records, your UDI tracking—all must be formally controlled, documented, and traceable. This isn't new thinking, but the requirements are now explicit and auditable.
Section 820.45 now explicitly governs device labeling and packaging controls with documented procedures and inspection protocols. Manufacturers must establish procedures for controlling device labeling and packaging to ensure that labeling and packaging specifications are met.
Again, these aren't new concepts. They're clarifications of existing expectations, now formally required under QMSR.
This is the critical question for device designers and development teams.
The FDA has stated that design control requirements in the QS regulation and QMSR are substantially similar. The fundamental principles of design verification and validation haven't changed. Your design input, design output, design verification, and design validation processes follow the same core logic.
What has changed is the organizational framework and documentation structure.
Your design history file, traceability matrices, risk management documentation, and design control records must now align with ISO 13485 requirements and terminology. The actual design process may not change dramatically, but how you organize, document, and trace design activities must now map to ISO 13485 clauses and expectations.
For companies already operating on ISO 13485 principles, this transition is straightforward. Your documentation structure likely already aligns with QMSR expectations.
For organizations relying on legacy QS regulation practices - companies that have structured their design controls, documentation, and quality systems around the old 15-subpart framework - meaningful restructuring is required. Your design history file must be reorganized. Your traceability must be re-established using ISO 13485 terminology. Your risk management documentation must be mapped to ISO 13485 clauses.
This is not trivial work. But it's manageable when approached systematically.
The deadline is real. February 2, 2026, is not far away. However, FDA investigators may review records created before February 2, 2026, to assess compliance with QMSR requirements. This means the transition period isn't truly a grace period, it's an assessment period.
If you're designing new devices now, start with QMSR-aligned processes and ISO 13485 documentation structures. If you're transitioning existing products, begin your documentation work immediately. Your quality system, design controls, and regulatory documentation must be aligned before February 2, 2026, deadline arrives.
The QMSR transition is a regulatory reality. It's not something that can be avoided or delayed. Understanding what's changing, assessing your current position, and planning your transition is critical.
Organizations that begin now will be positioned and compliant. Those that wait will face compressed timelines and potential inspection findings.
The good news: The changes aren't revolutionary. The design and development principles remain sound. It's the organization, documentation structure, and alignment with ISO 13485 that requires attention.
Start now. Plan systematically. Align your quality system with ISO 13485. When February 2, 2026, arrives, you'll be ready.
