FDA Issues Draft Guidance on QMS Information for Premarket Submissions

Breaking Down the FDA’s Draft Guidance on QMS Information for Premarket Submissions

The medical device industry is in the final countdown for the implementation of the Quality Management System Regulation (QMSR), which officially takes effect on February 2, 2026. As a critical companion piece to this monumental shift, the FDA has released the draft guidance, "Quality Management System Information for Certain Premarket Submission Reviews." This document is essential reading, not just for manufacturers submitting Premarket Approvals (PMAs) and Humanitarian Device Exemptions (HDEs), but for every company navigating the new global quality system landscape.

This breakdown dissects the guidance, focusing on its core intent, the operational impact, and the critical path for manufacturer alignment.

The FDA’s Driving Intent: Harmonization and Clarity

The timing and purpose of this draft guidance are directly tied to the QMSR Final Rule. The FDA is addressing two primary needs:

A.) Formalizing the QMSR Transition 

The guidance is an explicit response to the QMSR's move to incorporate ISO 13485:2016 (Medical devices — Quality management systems — Requirements for regulatory purposes) by reference.

Goal: To clarify FDA expectations for the QMS information manufacturers must include in their marketing submissions stemming from the new QMSR.

Replacement: When finalized, this guidance will officially supersede the outdated 2003 guidance on QMS information, which was based on the old, pre-harmonized Quality System Regulation (QSR).

The Mandate: It confirms that the FDA expects documentation to reflect a system compliant with the international standard, thereby fostering global alignment in regulatory submissions.

B.) Satisfying Statutory Requirements 

Under the Federal Food, Drug, and Cosmetic Act, PMAs (and by extension, HDEs) must include information demonstrating that the device is manufactured in accordance with the current good manufacturing practice (CGMP) requirements. This guidance specifies what type of QMS evidence is necessary to satisfy that statutory requirement under the new QMSR structure.

Key Themes in FDA’s Draft Guidance

This guidance provides a roadmap for FDA reviewers and inspectors, highlighting the areas of QMS documentation they will focus on during the premarket review phase.

Summary of Key Themes Found in FDA's Draft Guidance on QMS Information for Certain Premarket Submission Reviews

The impact of this draft guidance is immediate and multifaceted, directly affecting manufacturers of high-risk devices.

Mandatory Compliance Transition

Manufacturers must ensure their QMS transition to the QMSR is complete well ahead of the February 2, 2026, deadline. Submissions made near or after this date will be reviewed against the new standard. This means:

• Quality Manual Updates: Re-structuring the Quality Manual and high-level procedures to align with the clauses of ISO 13485:2016.
  
  
• Updated SOPs: Revising detailed standard operating procedures (SOPs) for design, purchasing, manufacturing, and corrective and preventive actions (CAPA) to reflect the new regulatory language and focus.

Streamlined Global Regulatory Strategy (The Benefit)

The shift to ISO 13485:2016 is a massive advantage. By aligning the U.S. requirements with the global standard, manufacturers can:

• Reduce Documentation Duplication: Use a single, harmonized QMS for U.S. PMAs and global technical documentation (e.g., EU MDR/IVDR), significantly reducing the burden of managing disparate systems.
  
  
• Improve Efficiency: Use the same risk-based tools and terminology accepted by multiple regulatory bodies, leading to more efficient device development and submission preparation.
  

FDA’s Underlying Shift Towards a Science-Based Approach to Medical Device Regulation

The most valuable takeaway from this guidance is the FDA’s underlying shift in philosophy; a change that impacts all device manufacturers, not just those with PMAs.

The FDA is moving away from the highly prescriptive, compliance-first approach of the old QSR toward an ISO-based process maturity model.

Focus on Process Maturity: The documentation requested will be used to assess the maturity and effectiveness of the manufacturer’s processes. This means simply having a document is not enough; the submission must reflect that the QMS is actively managed, risk-based, and integral to the device's quality throughout its lifecycle.

Risk-Based Assessment is Key: ISO 13485 demands a comprehensive risk-based approach to the QMS. The FDA will expect to see how risk management principles are integrated into design controls, supplier controls, and production processes, an area that may require more explicit documentation than under the previous QSR.

Implications for 510(k) Submissions: While this guidance focuses on PMAs/HDEs, the QMS philosophy it outlines will inherently influence all CDRH personnel. Manufacturers submitting 510(k)s should consider this guidance as an indicator of the FDA’s "current thinking" regarding a fully compliant QMSR system. A robust, ISO-aligned QMS will be the expected norm during any future facility inspection, regardless of the device class.

Actionable Recommendations for Alignment

To align your company with the expectations outlined in this draft guidance, manufacturers should take these steps immediately:

1. Finalize the QMSR Transition: Ensure all QMS documentation, processes, and training are fully transitioned from QSR language to QMSR/ISO 13485:2016 language and structure.
   
   
2. Update Submission SOPs: Revise your standard operating procedures for generating PMA/HDE submissions. The quality section of these dossiers must be organized to present QMSR evidence logically, focusing on the required elements of design control, risk management, and manufacturing readiness.
   
   
3. Conduct a Gap Analysis of PAI Evidence: Use the guidance to preemptively assess the readiness of your manufacturing site for a Pre-Approval Inspection. Verify that the QMS documentation you submit matches the processes on the floor, especially for novel or high-risk manufacturing steps.
   

This draft guidance confirms the shift to a globally harmonized regulatory future. By treating it as a strategic document rather than a compliance checklist, manufacturers can position themselves for smoother premarket reviews and successful transitions into the QMSR era.

Streamline Your QMSR Readiness with Rook Quality Systems

Navigating the evolving FDA regulatory landscape can be complex, especially with the QMSR transition and the increasing emphasis on risk-based, ISO-aligned quality systems. 

Rook Quality Systems helps manufacturers prepare for this new era by providing tailored support in QMSR compliance, including gap assessments, SOP and Quality Manual updates, and guidance for PMA/HDE submission readiness. We assist companies in aligning their processes with ISO 13485:2016, integrating risk management into design and manufacturing, and ensuring that Pre-Approval Inspection (PAI) evidence is complete and inspection-ready.

With Rook as a partner, medical device manufacturers can streamline their regulatory strategy, reduce compliance risk, and confidently navigate FDA expectations in the QMSR era.