FDA readies for QMSR implementation with draft QMS information guidance: What manufacturers need to know

The QMSR incorporates by reference ISO 13485:2016 and ISO 9000:2015 Clause 3 and in doing so replaces FDA's long-standing quality system (QS) regulation. That shift is intended to harmonize U.S. quality expectations with global device frameworks and reduce duplicative regulatory obligations. But as the draft guidance reflects, the shift also increases the level of documentation—especially related to risk management and design and development controls—that manufacturers must demonstrate in PMAs.

Industry has 60 days to submit comments on the draft guidance after it is published in the Federal Register.

Key compliance expectations introduced in the draft guidance

With the transition to the QMSR, FDA now expects manufacturers to demonstrate up front in PMA documentation the quality controls needed to ensure device safety and effectiveness, not leave them for pre-approval inspection. Highlighted below are FDA’s most significant expectations under the draft guidance—and where manufacturers should expect deeper scrutiny going forward.

• FDA now expects documentation that shows the QMS is fundamentally risk-based and aligned with ISO 13485:2016. Unlike the 2003 guidance, which was anchored in U.S.-centric current good manufacturing practices, the draft guidance emphasizes that risk-based decision-making must permeate process control, outsourced manufacturing oversight, and QMS software validation. ISO subclause-linked summaries are required to show how risks are analyzed and controlled—and how those controls are verified for effectiveness across the device lifecycle.
• FDA requires more comprehensive QMS documentation—including design history documentation and traceability—directly in submissions. Manufacturers must provide written procedures, summaries, reports, or lists addressing QMSR elements, including quality policy and objectives, quality manual, document control, supplier controls, environmental controls, cleanliness and contamination controls, and risk-based maintenance strategies. Although FDA may interactively request additional documentation, a robust submission upfront can streamline pre-approval inspections, reduce pre-approval inspection scope, and avoid review delays. That is a material shift from 2003, when many of these materials were typically reviewed as part of the pre-approval inspection, not submitted in advance.
• Design and development control documentation must be both current and device-specific—with verification and validation strategies fully transparent. Submitters must demonstrate how design plans were executed; how inputs trace to outputs; how verification and validation confirm essential performance and usability; and how management reviews evaluate design effectiveness for the device. FDA also expects traceability matrices, change history summaries, and justification that any changes after initial verification and validation do not invalidate prior evidence—including clinical data supporting safety and effectiveness.
• QMS evidence must reflect effectiveness of outsourced activities and supplier performance—proportionate to risk. Where contract manufacturers or suppliers are used, manufacturing files must show supplier evaluation criteria, ongoing monitoring methods, and risk-based controls over purchased product quality. The 2003 guidance contemplated purchasing controls but lacked the risk-tiered rigor and ISO formalism now required.
• Submission documentation should support FDA in narrowing and targeting pre-approval inspections—not simply deferring quality assessment until inspection. The draft guidance emphasizes that QMS information “may reduce or eliminate” follow-on requests and help FDA focus the preapproval inspection process. This shifts expectations from “show us when we arrive” toward “show us before we schedule the inspection.”
• FDA expects environmental and contamination controls to be risk-justified and validated—including representative cleanroom qualification records. Because environmental controls can vary by device type, FDA requires a clear risk-based rationale for relevant controls such as a cleanroom or personnel gowning requirements. Manufacturers should be prepared to provide validation protocols and reports for these environmental processes directly in the PMA.
• Inspections beginning February 2, 2026, will evaluate compliance with QMSR, and submissions filed after that date must include QMSR-aligned documentation. Gap analyses or comparative assessments are recommended where legacy QS-structured files remain in use. The agency encourages Q-Submission program engagement to resolve uncertainties before filing—another change reflecting FDA’s least-burdensome expectations for coordination.

Practical action items for device manufacturers

While the draft guidance raises expectations for documentation quality and transparency, it also provides manufacturers an opportunity to streamline inspection readiness and shorten review cycles—if addressed early. The action steps below reflect our interpretation of the draft guidance and translate it into concrete operational tasks that QMS and regulatory teams can begin implementing now, ahead of the February 2026 QMSR compliance deadline. While the draft guidance recommends some of these elements explicitly, others are included based on our experience and judgment to support a more robust and inspection-ready submission strategy.

• Conduct a QMSR-specific gap analysis using ISO 13485 structure as the organizing backbone if documents and records were created using pre-QMSR standards. FDA expects ISO terminology and documentation sequencing, so a comparative assessment could be essential to demonstrating QMSR compliance.
• Strengthen traceability of design history files across inputs, outputs, risk controls, verification, and validation. Submitters must tell a complete story showing how each identified risk led to specific design requirements, how those requirements were translated into design outputs, and how verification and validation testing prove that those outputs were incorporated into the device and ensure its safe and effective performance. Each user need or design input should be linked to risk, and the risk documentation should clearly show how mitigations were made in the design process. A comprehensive trace matrix which maps user needs to inputs, outputs, verification and validation, associated portions of risk management plans through to design transfer would help accomplish this expectation.
• Validate cleanrooms, sterilization processes, and contamination controls early—with protocols and certain reports ready at submission. Submitters must include the applicable control procedures for the production environment and a representative validation plan protocol which identifies measurable acceptance criteria, and reports for key processes such as cleaning and cleanroom qualification.
• Align supplier controls and change notification requirements with risk ranking. Submitters must show that their supplier controls are proportionate to the risk that suppliers introduce to the safety and effectiveness of the finished device. Associated supplier qualification procedures should define classifications of suppliers by risk, and include the criteria required for qualification and ongoing controls by classification.
• Strengthen management review records to allow device-specific submission summaries. Submitters must demonstrate how top management evaluated effectiveness of the QMS for the subject device. Additionally, recall that FDA will now be able to review management review materials.
• Plan for modular submission sequencing using eSTAR to avoid documentation drift. This is essential for multi-facility device realization and ongoing submission iterations.
• Engage early with FDA through Q-Submissions for alternate approaches and update legacy documents and records. FDA encourages proactive coordination to avoid review delays or deficiencies and indicates that alternate documentation strategies can be acceptable—if aligned before submission. This may require revision of legacy records to conform to the new requirements for PMA supplement submissions, such as 180-day supplements which historically leveraged previously submitted documentation from the base PMA.

How we can help

The shift to QMSR-aligned submission reviews represents a fundamental change in what FDA expects to see in a PMA and when FDA expects to see it. Although the guidance applies to PMA devices, it does provide insight into FDA’s QMSR expectations more generally. The stakes are high: incomplete or inconsistent QMS documentation can be treated as a statutory insufficiency under Section 515(d)(2)(C), creating real risks of delays, scope expansions during inspection, or even denial.

Legal counsel who understand both the substance of QMSR and the strategic realities of PMAs can help manufacturers:

• Translate ISO 13485-aligned expectations into FDA-ready submission content.
• Confirm that device-specific design and risk documentation will withstand reviewer and investigator scrutiny.
• Guide Q-Submission interactions to secure alignment with FDA on compliance approaches before filing.
• Work with internal teams and suppliers to harmonize controls across facilities and documentation sets.
• Develop remediation strategies where legacy QS records do not yet support a QMSR review standard.
• Ensure that documentation supporting contract manufacturer oversight is legally and regulatorily robust.
• Convert legacy QSR-oriented SOPs and work instructions to be QMSR compliant.

As FDA increasingly conducts its quality assessment within the submission review rather than solely at inspection, counsel experienced in device quality regulation, and in particular the differences between FDA’s historic expectations and the requirements set forth in the draft guidance, can be the difference between a file that moves and one that stalls. The companies who start aligning their documentation strategy now—with the right regulatory and legal guidance—will be best positioned to maintain speed to market once the QMSR takes effect.

Our team advises device and combination-product manufacturers navigating QMSR transition planning, inspection readiness, design controls, and post-market quality obligations. We are actively supporting clients with QMS documentation mapping, QMSR readiness and compliance, submission modernization, and facility alignment projects tailored to their risk profiles and product portfolios.

Contact us today to schedule a consultation or to discuss how we can support your business through this evolving regulatory landscape.

Authored by Jodi Scott, Michael Heyl, Randy Prebula, Wil Henderson, and Greg Kass.