5 Things You Need to Know About the FDA’s QMSR Before 2026

Five Things You Need to Know to Prepare for QMSR

The U.S. medical device industry is heading toward one of the most significant regulatory shifts in decades. On February 2, 2026, the FDA’s new Quality Management System Regulation (QMSR) will officially replace the long-standing Quality System Regulation (QSR) under 21 CFR Part 820. This new final rule is officially known as the "Medical Device Current Good Manufacturing Practice (CGMP) Requirements."

For quality and regulatory leaders, this isn’t just a paperwork update, it’s a full modernization of how quality systems are expected to operate. The goal is to align U.S. medical device regulations with ISO 13485:2016, the international gold standard for quality management in the medical device sector.

1. QMSR Aligns the U.S. with Global Standards

The FDA’s intent is to simplify global compliance. Historically, manufacturers selling devices in both the U.S. and abroad had to maintain two parallel systems—one for FDA’s QSR and one for ISO 13485.

Under the new QMSR, the FDA will incorporate ISO 13485:2016 by reference, meaning the same foundational requirements now apply worldwide. That means less duplication, fewer conflicting procedures, and a single quality language shared across regions.

However, don’t assume ISO 13485 certification equals QMSR compliance. The FDA will still require additional elements specific to the U.S., such as detailed complaint handling, labeling controls, and post-market surveillance expectations.

2. Risk Management Now Runs Through the Entire QMS

Under the old QSR, risk was largely confined to design controls—evaluating product risk during development. QMSR takes a more modern approach: risk-based thinking is now expected across all quality processes.

That means supplier selection, process validation, internal audits, and even management reviews should demonstrate a risk-driven rationale. This shift also requires a stronger connection between your post-market surveillance data (complaints, nonconformances) and your design and risk management files, ensuring feedback drives continuous product improvement. Organizations must be able to show that decisions—whether accepting a supplier, approving a process change, or handling a nonconformance—are proportionate to the level of risk they pose to product safety and performance.

This shift will demand better data visibility, stronger documentation, and digital systems capable of connecting risks across functions.

3. FDA Inspections Will Change—Significantly

The FDA plans to retire the familiar QSIT (Quality System Inspection Technique) and replace it with a new inspection approach aligned with QMSR.

Perhaps the biggest change: the FDA will now have access to previously exempt records—including internal audit reports, supplier audits, and management review outputs. These are no longer off-limits.

For manufacturers, that means internal documentation must not only exist—it must withstand regulatory scrutiny. Expect greater focus on management accountability and the completeness of your quality records.

4. Terminology and Structure Are Modernizing

The QMSR updates several legacy QSR terms to match ISO conventions. For example:

• The QSR's "Purchasing Controls" terminology has evolved into the more comprehensive concept of "Supplier Processes," emphasizing the lifecycle management and risk assessment of external partners.
• “Device Master Record (DMR)” and “Device History Record (DHR)” will now fall under the broader concept of a Medical Device File.
• Definitions for labeling, packaging, and complaint handling are harmonized with ISO 13485.
• “Design History File (DHF)” terminology remains but is reframed to align with international documentation practices.

Organizations will need to update internal SOPs, forms, and training materials to reflect this modernized vocabulary and structure.

5. The Time to Act Is Now

February 2026 is just around the corner. Completing a QMSR gap analysis can take months—especially for organizations that built their quality systems exclusively around the old QSR.

Start with:

• Mapping your processes against ISO 13485 and the FDA’s QMSR add-ons.
• Updating documentation to embed risk-based thinking.
• Ensuring supplier audits, management reviews, and internal audits are fully documented and accessible.
• Training leadership and quality teams on the upcoming inspection changes.

The Bottom Line

The QMSR represents a long-awaited modernization that brings the FDA in step with global best practices. For proactive manufacturers, it’s an opportunity to streamline compliance, strengthen risk management, and demonstrate a culture of quality that transcends checklists.

Waiting until 2026 to prepare could mean scrambling to fill documentation gaps—or worse, facing non-compliance findings. Start now, align your QMS with ISO 13485, and use this transition as a catalyst to modernize your entire quality ecosystem.

Ready to modernize your QMS? Intellect helps manufacturers digitize and automate QMS processes, making it easier to comply with ISO 13485 and the FDA’s new QMSR. Learn how we can help you prepare for 2026 and beyond.