The FDA has released a draft guidance titled “Quality Management System Information for Certain Premarket Submission Reviews”, outlining how manufacturers must demonstrate their Quality Management System (QMS) compliance under the upcoming Quality Management System Regulation (QMSR).
The QMSR, set to take effect on 2 February 2026, represents one of the most significant changes to U.S. medical device quality requirements in decades. The new framework aligns the FDA’s expectations more closely with ISO 13485:2016, creating a globally harmonised approach to quality management while retaining U.S. specific requirements for risk management, documentation, and inspection readiness.
This blog explores what the guidance means for manufacturers and what practical steps you should take now to prepare your organisation and premarket submissions.
A Shift Towards Global Alignment
Historically, the U.S. Quality System Regulation (21 CFR Part 820) has operated independently from ISO 13485. With the introduction of the QMSR, this will change.
The FDA intends to harmonise its quality system requirements with ISO 13485, reducing duplication for companies operating in multiple markets. However, the new regulation and draft guidance make clear that ISO 13485 compliance alone will not be sufficient; manufacturers must still provide specific documentation tailored for U.S. regulatory review.
What the FDA Expects in Future Submissions
The draft guidance outlines what must be included in premarket submissions, including Premarket Approvals (PMAs) and Humanitarian Device Exemptions (HDEs) once the QMSR takes effect.
Key expectations include:
QMS description aligned to ISO 13485 clauses
Manufacturers must include a comprehensive QMS description mapped to ISO 13485 sub-clauses, covering management responsibility, resource management, product realisation, and measurement, analysis, and improvement.
Risk-based approach throughout the QMS
Risk management must extend beyond design controls to encompass supplier management, process validation, environmental control, and contamination prevention.
Supporting documentation
Manufacturers should not merely reference procedures. The FDA expects copies or summaries of key SOPs, validation reports, or lists of controlled documents to support your QMS description.
Multi-site identification
If your organisation uses multiple sites for manufacturing, processing, packaging, or installation, each facility must be clearly identified, along with its activities and corresponding QMS information.
Cover letter and submission format
Submissions should include a cover letter listing the facility address, FEI number, DUNS number, contact details, and inspection readiness date. The FDA encourages consistent formatting, especially for modular PMA submissions.
Design and development controls
For clauses corresponding to ISO 13485 Sections 7.3 and 7.5, manufacturers should include documentation showing traceability from design inputs to outputs, verification, validation, and change control justifications.
Supplier and purchasing controls
Suppliers and contract manufacturers must be qualified and monitored proportionate to risk. Expect to provide supplier lists, evaluation summaries, and records of purchased product verification.
Infrastructure and environmental control
Under “resource management,” manufacturers should include facility diagrams, maintenance records, and where relevant cleanroom validation for devices at contamination risk (e.g., implants, sterile devices).
Inspection readiness and legacy data
From 2026 onwards, FDA inspections will assess compliance with QMSR (not the legacy Quality System Regulation). Manufacturers should ensure historical data and validation records meet the new risk-based expectations.
What Manufacturers Should Do Now
Transitioning to QMSR readiness requires proactive planning. The FDA advises companies to begin preparing well before the February 2026 implementation date.
Recommended steps:
- Conduct a gap assessment
Compare your existing QMS against ISO 13485 and the forthcoming QMSR. Identify deficiencies in supplier controls, documentation, and traceability. - Strengthen documentation for submissions
Ensure SOPs, validation reports, and traceability matrices are written not just for internal use but for regulatory review clarity. - Clarify multi-site responsibilities
Prepare clear maps of site roles and responsibilities, with process flow diagrams that show which entity controls each manufacturing or testing step. - Engage early with the FDA
The draft guidance encourages the use of the Q-Submission programme for clarification or alternative approaches to QMS evidence. - Update internal procedures
Revise supplier qualification, environmental validation, change control, and CAPA processes to reflect a risk-based philosophy. - Train your teams
Quality, regulatory, and manufacturing staff, especially management, must understand their responsibilities under QMSR, including internal audit, management review, and CAPA expectations.
The Broader Impact of QMSR
Global consistency
Manufacturers with ISO 13485 certification will benefit from reduced duplication and easier documentation alignment across markets.
More evidence-based reviews
The FDA will expect deeper insight into how the QMS operates, not just policies, but tangible records of implementation.
Stronger supplier oversight
The shift to risk-based purchasing controls places greater accountability on manufacturers for the integrity of their supply chains.
Improved readiness for inspections
FDA investigators will now assess conformity under QMSR, evaluating how manufacturers demonstrate ongoing control rather than static compliance.
Preparing for 2026 and Beyond
The QMSR’s introduction signals a new era for quality management in U.S. medical device regulation.
To stay ahead:
- Start aligning your QMS now with ISO 13485 principles and FDA-specific evidence expectations.
- Review legacy validation and change control documentation for consistency.
- Ensure your submission teams can present clear, traceable, and risk-based documentation when QMS information is requested.
Early preparation will not only prevent compliance gaps it will also position your organisation for a smoother transition, faster approvals, and fewer post-inspection surprises.
LFH supports manufacturers in preparing for the transition to the FDA’s Quality Management System Regulation (QMSR). From QMS gap assessments and ISO 13485 integration to submission document preparation and audit readiness, our consultants ensure your organisation is fully compliant and inspection-ready by 2026.
FAQs – (QMRS 2026)
When does the FDA’s QMSR take effect?
The final rule is expected to take effect on 2 February 2026.
Does ISO 13485 certification automatically mean compliance?
No. ISO 13485 alignment helps, but manufacturers must provide FDA-specific documentation demonstrating QMSR conformity.
Will this affect 510(k) submissions?
Primarily, it applies to PMA and HDE submissions, but similar expectations may appear in other device review processes over time.
Should legacy data be updated?
Yes. Validation, supplier, and environmental control records created under the previous QS Regulation should be reviewed and aligned with the QMSR approach.
