Understanding the QMSR: What Changed for Medical Device Quality Systems on February 2, 2026 (Part 1)

As of February 2, 2026, the FDA's Quality Management System Regulation (QMSR) has replaced 21 CFR Part 820 as the foundation for medical device quality systems in the United States. This transition incorporates ISO 13485:2016 by reference, harmonizing U.S. requirements with international quality management standards used by regulatory authorities worldwide.

For medical device manufacturers, CROs, and regulatory affairs professionals, understanding what changed is essential for maintaining compliance, preparing for FDA inspections, and ensuring continued market access.

What Is the QMSR?

The QMSR maintains the integrated quality system structure that governed medical devices under 21 CFR Part 820, covering design controls, production processes, validation, packaging, labeling, complaint handling, and corrective action. The fundamental goal remains unchanged: ensuring that finished devices meet specified requirements and perform reliably in their intended use.

What's different is the regulatory framework. By incorporating ISO 13485:2016 by reference, the QMSR aligns U.S. requirements with the international consensus standard for medical device quality management systems. The FDA determined that ISO 13485:2016 requirements are substantially similar to the former Quality System Regulation, providing equivalent assurance of device safety and effectiveness while harmonizing with global regulatory expectations.

The QMSR applies to all medical device manufacturers operating in the United States, regardless of device classification or regulatory pathway. Whether you manufacture Class I accessories, Class II devices requiring 510(k) clearance, or Class III devices with PMA approval, you now operate under the QMSR framework.

Why FDA Made This Change

The transition to the QMSR represents FDA's commitment to regulatory harmonization and modernization. By aligning with ISO 13485:2016, FDA aims to:

• Reduce regulatory burden for manufacturers operating in multiple global markets by creating consistency between US and international quality system requirements.

  
  

• Promote device quality and safety through adoption of internationally recognized best practices that have proven effective in other regulatory jurisdictions.

  
  

• Facilitate market access by harmonizing requirements, potentially reducing duplicative assessments and enabling more efficient product introductions.

  
  

• Support innovation by creating a more predictable regulatory framework aligned with global standards.

This harmonization effort continues FDA's broader strategy of international cooperation and regulatory convergence, making it easier for manufacturers to bring safe, effective devices to patients worldwide.

What Stayed the Same

If your quality system was compliant with 21 CFR Part 820 on February 1, 2026, the fundamental structure and controls remain valid under the QMSR. Core principles that continue include:

• Design controls for Class II and III devices (and some Class I devices) covering design planning, inputs, outputs, verification, validation, transfer, and change control.

  
  

• Management responsibility requiring executive oversight, quality policy, resource allocation, and management review of QMS effectiveness.

  
  

• Document and record controls ensuring procedures are reviewed, approved, current, and traceable throughout the device lifecycle.

  
  

• Purchasing controls requiring supplier evaluation, monitoring, and verification of purchased materials and services.

  
  

• Production and process controls including validated processes, environmental controls, equipment qualification, and process monitoring.

  
  

• Acceptance activities at incoming, in-process, and finished device stages with defined criteria and documented results.

  
  

• Nonconforming product controls requiring identification, segregation, review, and documented disposition of deviations.

  
  

• Corrective and preventive action (CAPA) systems for investigating issues, determining root causes, implementing corrections, and preventing recurrence.

  
  

The FDA explicitly recognized that these fundamental requirements provide equivalent assurance of device safety whether implemented under Part 820 or the QMSR framework.

Critical Changes Under the QMSR

While core principles remain consistent, several important changes became effective February 2, 2026:

Expanded FDA Inspection Authority

The most immediate operational change affects what FDA can review during inspections. Under the QMSR, FDA now has explicit authority to inspect:

Management review reports documenting executive review of QMS effectiveness, including review inputs, outputs, decisions, and follow-up actions.

Internal audit reports showing systematic assessment of QMS compliance and effectiveness, findings, corrective actions, and verification of action effectiveness.

Supplier audit reports demonstrating evaluation of supplier capability, performance monitoring, and ongoing qualification.

These documents were previously exempt from routine FDA review under 21 CFR Part 820.180(c). That exemption no longer exists. FDA investigators conducting inspections after February 2, 2026, may request and review these records as part of standard QMS assessment.

Practical implication: These documents must be maintained as inspection-ready records demonstrating systematic quality management, data-driven decision-making, and continuous improvement. They are no longer internal-only documents.

New FDA Inspection Process

FDA retired the Quality System Inspection Technique (QSIT) on February 2, 2026. All inspections now follow Compliance Program 7382.850, which aligns with ISO 13485:2016 structure while maintaining FDA-specific requirements.

Key aspects of the new inspection process:

• Process-based assessment evaluating how your QMS functions as an integrated system rather than checking isolated procedures.

  
  

• Review of historical records including documents created before February 2, 2026. FDA expects manufacturers to demonstrate that pre-transition records meet current QMSR requirements through comparative analysis.

  
  

• Focus on effectiveness assessing whether your QMS actually drives product quality and safety, not just documentation compliance.

  
  

• Alignment with ISO 13485 structure while maintaining FDA authority and expectations under the Federal Food, Drug, and Cosmetic Act.

ISO 13485:2016 Incorporation by Reference

The QMSR incorporates ISO 13485:2016 as a referenced standard, with FDA-specific additions that clarify expectations and ensure consistency with US regulatory requirements.

Important clarifications about ISO 13485 and the QMSR:

No certification required: FDA does not require or issue certificates of conformance to ISO 13485. Having an ISO 13485 certificate does not exempt your facility from FDA inspection.

Regulatory compliance vs. standard conformance: FDA inspections assess compliance with the QMSR (a regulation), not conformance to ISO 13485 (a standard). While the requirements are substantially similar, FDA enforces regulatory requirements.

MDSAP remains separate: The Medical Device Single Audit Program (MDSAP) remains a voluntary third-party audit program. MDSAP participation does not replace FDA inspections or change QMSR compliance obligations.

Standard access: Manufacturers can access ISO 13485:2016 and ISO 9000:2015 Clause 3 (both incorporated by reference) in read-only format through the ANSI Incorporated by Reference Portal at https://ibr.ansi.org/Standards/iso1.aspx.

What Manufacturers Should Do Now

One week into the QMSR era, manufacturers should focus on immediate compliance priorities:

Ensure inspection readiness for management review reports, internal audit reports, and supplier audit reports. These documents must demonstrate systematic quality management and be readily available for FDA review.

Verify documentation currency by confirming that quality system procedures reference QMSR requirements and align with ISO 13485:2016 terminology where appropriate.

Conduct comparative analysis showing that records created before February 2, 2026, meet current QMSR requirements. Document any gaps and corrective actions taken.

Train staff on QMSR requirements, particularly changes in inspection authority and the new FDA inspection process under Compliance Program 7382.850.

Review change control processes to ensure material changes, supplier changes, and process modifications are evaluated for QMSR compliance impact, including biocompatibility reassessment where applicable.

Prepare for FDA interactions by understanding how the new inspection process differs from QSIT and what FDA will evaluate during QMSR compliance assessments.

Biocompatibility Under the QMSR

Biocompatibility evaluation remains a critical component of device safety assessment under the QMSR, now integrated with ISO 13485:2016 quality system requirements and ISO 10993-1:2025's risk-based biological evaluation framework.

The QMSR requires biocompatibility considerations to be embedded in:

• Design controls where material selection, patient contact categorization, and biological risk assessment inform design inputs and verification activities.

  
  

• Risk management where biological hazards are identified, risks are estimated, and controls are implemented and verified.

  
  

• Change control where material changes, process modifications, or supplier changes trigger reassessment of biological safety.

  
  

• Post-market surveillance where complaints or adverse events related to biological effects feed into CAPA and risk management updates.

Under ISO 10993-1:2025, manufacturers must conduct systematic biological risk assessment rather than following a prescriptive testing matrix. This risk-based approach aligns well with the QMSR's emphasis on process-based quality management and requires:

• Identification of biological hazards based on device characteristics

• Estimation of biological risks using available information

• Determination of what additional information (if any) is needed

• Scientific justification for all testing decisions

This integration of biocompatibility with quality systems will be explored in detail in a separate part of this series.

Expert QMSR Compliance and Biocompatibility Strategy

Successfully navigating the QMSR transition requires strategic integration of quality system compliance, biocompatibility evaluation, and regulatory expertise. At JL Tox Consulting, we help medical device manufacturers and CROs adapt to QMSR requirements while maintaining efficient product development and regulatory submission processes.

Our QMSR compliance support services include:

• Gap analysis comparing existing QMS to QMSR and ISO 13485:2016 requirements

• Inspection readiness preparation for management reviews, internal audits, and supplier audits now subject to FDA review

• Biocompatibility integration with ISO 10993-1:2025 risk-based evaluation frameworks embedded in design controls

• Documentation updates ensuring QMSR compliance and FDA inspection readiness

• Training and implementation support for quality, regulatory, and technical teams

• FDA deficiency response addressing QMSR compliance and biocompatibility questions

With over a decade of specialized experience in medical device biocompatibility and quality system integration, Dr. James Lyons and the JL Tox team provide the expertise needed to navigate QMSR compliance efficiently and effectively.

Contact JL Tox Consulting to ensure your quality system meets current QMSR requirements.

Email: info@JLTox.com

Phone: (877) 899-6568