5 Design Control Gaps the FDA Will Target Under QMSR

The FDA’s Quality Management System Regulation (QMSR), effective February 2, 2026, represents more than a regulatory update—it fundamentally changes how design controls are evaluated during inspections.

As the FDA aligns 21 CFR 820 with ISO 13485, inspectors will move beyond checking whether design control documents exist. Instead, they will assess whether design controls function as a connected, traceable system that integrates risk management, verification, validation, and change control.

Below are five design control gaps the FDA will increasingly target under QMSR, and why many medical device companies may not be prepared.

1.  Technical Documentation That Doesn’t Function as a System 

Under QMSR, the FDA aligns with ISO 13485 and shifts away from treating the Design History File (DHF) and Device Master Record (DMR) as separate standalone documents. Instead, inspectors will now evaluate whether an organization maintains integrated technical documentation, often called the Medical Device File, that functions across the entire product lifecycle.

The FDA will not be looking just for the presence of specific files, but rather whether the technical data:

• Clearly demonstrates design intent and evolution
• Integrates risk management throughout the lifecycle
• Connects design, manufacturing, suppliers, labeling, packaging, and postmarket information
• Remains consistent and traceable as changes occur

Under QMSR, fragmentation becomes a critical weakness as inspectors will be looking for team to explain their products using one coherent body of technical data, not by jumping between disconnected documents and systems.

When technical documentation does not operate as an integrated system, the FDA will view it as evidence that design controls and risk are not truly under control, regardless of how complete individual documents may be.

2. Weak Traceability Between Design Controls and Risk Management 

Traceability has always been required, but QMSR raises the standard. FDA inspectors will increasingly ask:

• How is each risk mitigated, is there a specific design input or output?
• Where is that risk verified or validated?
• How is traceability maintained when changes occur?

Manual traceability matrices and spreadsheets often fail under real-world change. Under QMSR, the FDA expects traceability to be continuous and reliable, not reconstructed during an audit.

3.  Static Risk Management Files 

Risk management under QMSR must be a living process, aligned with ISO 14971 expectations. The FDA will likely focus on whether:

• Risk is considered early (and often)
• Risks evolve alongside design changes
• Risk controls remain effective and verified
• Post-market feedback informs risk updates

Static risk files, updated only at milestones or during inspections, suggest that organizations are just documenting risk rather than actively managing it.

4. Poor Change Impact Analysis Across Design Controls

Design changes expose the weakest design control systems. Under QMSR, the FDA will evaluate, amongst other things,:

• How design changes affect requirements, risks, process, and verification activities
• Whether impacts are assessed consistently and completely
• How changes propagate across the medical device file
• How do changes to process or suppliers impact design or risk

Document-based change processes often miss downstream impacts, creating traceability gaps that surface during inspections or production—when remediation is most costly.

5.  Design Decisions Locked in Documents  

The FDA does not just evaluate what decisions were made but why they were made. When design rationale is buried in informal discussions, disconnected documents, emails, etc.:

• Context is lost
• Traceability gaps emerge
• Decisions are difficult to justify over time

QMSR places greater emphasis on preserving design intent across the product lifecycle, not just in approved artifacts.

Why These QMSR Design Control Gaps Share a Common Root Cause

Each of these gaps points to the same underlying issue – design control systems built on disconnected documents and data instead of structured, traceable data.

Under QMSR, the FDA is evaluating whether design controls operate as an integrated system capable of withstanding change, inspection, and real-world complexity.

Organizations that discover these gaps during an FDA inspection will face:

• Extended and costly remediation efforts
• Engineering resource diversion
• Delayed product development and market entry

HOW TO ASSESS YOUR QMSR DESIGN CONTROL READINESS

QMSR enforcement will not overlook organizations that assume their existing design controls are “close enough.”

If you’re uncertain how your design control system will perform under QMSR-level scrutiny, it’s critical to assess gaps now—before the FDA does.

 Download the QMSR Design Control Readiness Checklist