--- title: "The QMSR Deadline Has Passed, but Companies Are Still Searching for Guidance" description: "The FDA QMSR is now in force. Learn where medical device and IVD manufacturers still struggle with QMSR compliance and what to prioritise next." url: https://qbdgroup.com/en/blog/qmsr-deadline-passed-still-searching-guidance type: "Blog post" language: en published: 2026-06-19 author: "Tiago de Matos Lourenço" category: "Quality Assurance" publisher: "QbD Group" citation: "QbD Group, \"The QMSR Deadline Has Passed, but Companies Are Still Searching for Guidance\", https://qbdgroup.com/en/blog/qmsr-deadline-passed-still-searching-guidance" --- # The QMSR Deadline Has Passed, but Companies Are Still Searching for Guidance > The FDA QMSR is now in force. Learn where medical device and IVD manufacturers still struggle with QMSR compliance and what to prioritise next. The date that the medical device industry circled for two years has come and gone. On February 2, 2026, the FDA's **Quality Management System Regulation (QMSR)** became effective and enforceable, replacing the former Quality System Regulation under **21 CFR Part 820** that had governed US device manufacturing since 1996. The transition period is over. The regulation now incorporates **ISO 13485:2016** by reference into 21 CFR Part 820, and the FDA has already retired its old inspection playbook in favour of a new one. And yet, months after the deadline, a striking number of manufacturers are still actively searching for guidance. Quality teams are asking the same questions they were asking before February: - What exactly does the QMSR expect of us? - Are we really compliant, or only mostly? - What will an inspector look at first? If your organisation is in that position, you are not behind the curve in any unusual way. You are part of a large group that is only now confronting what the QMSR means in practice rather than on paper. This post looks at why the questions did not stop when the deadline passed, where companies are still struggling, and what to prioritise now that enforcement is live. **In This Blog Post** - Why many manufacturers still feel unprepared after the QMSR deadline - Why ISO 13485 certification alone does not guarantee QMSR compliance - What has changed in FDA inspections under the QMSR - What medical device and IVD manufacturers should prioritise now - How to prepare for QMSR inspections with confidence ## A Deadline Is Not the Same as Readiness The clearest sign that the industry is still finding its footing comes from its own data. Survey work published after the deadline found that more than half of life science organisations describe themselves as only moderately prepared, or not prepared, for the QMSR. The reasons cluster into a handful of recurring themes: - Insufficient resources to overhaul processes - Resistance to change - Genuine confusion about what the regulation requires - Lack of leadership buy-in to drive the work forward None of those obstacles disappeared on February 2. If anything, the passing of the deadline brought them into sharper focus. Companies that treated the QMSR as a documentation exercise to be finished by a certain date are discovering that the regulation is really about how a quality system behaves day to day, and that is not something you complete and file away. ## The "We Are ISO 13485 Certified, So We Are Done" Trap The single most persistent misunderstanding, and a major driver of the continued search for guidance, is the assumption that an ISO 13485:2016 certificate equals QMSR compliance. It does not. The QMSR incorporates ISO 13485:2016 by reference, which means the standard now forms the backbone of US device quality requirements. However, the FDA layered additional requirements on top of the standard. These include FDA-specific obligations around: - Device labelling and packaging controls - Complaint and servicing records - **Unique Device Identification (UDI)** - **Medical Device Reporting** (21 CFR Part 803) The standard does not cover these areas in the way the FDA expects, which means a certificate alone leaves gaps. **Common QMSR Gap Areas** Even organisations with mature ISO 13485 systems frequently discover gaps in: - Device labelling and packaging controls - Complaint and servicing documentation - Unique Device Identification (UDI) - Medical Device Reporting (MDR) - FDA-specific design control requirements Just as importantly, the FDA has been explicit that it will neither require nor issue certificates of conformance to ISO 13485. Holding a certificate does not exempt a manufacturer from FDA inspection. A company can be fully certified and still receive findings if its system does not satisfy the FDA's additional expectations. This is precisely the type of nuance that continues to drive post-deadline questions. ## Inspections Have Already Changed For manufacturers, the most concrete change is how the FDA now inspects. On February 2, 2026, the agency withdrew the **Quality System Inspection Technique (QSIT)** that investigators had used for decades and began operating under a new Compliance Program, Inspection of Medical Device Manufacturers (**CP 7382.850**). The older inspection documents were retired on the same day. The new approach leans on a risk-based model, and it includes a detail that has caught some companies off guard: Investigators may review records created before February 2, 2026. Because the FDA considers the former QSR and the QMSR to be substantially similar, the agency can use pre-existing records to assess QMSR compliance. In practice, this means your historical documentation is in scope from the first QMSR inspection onward. The takeaway is simple: there is no grace period in which old records are ignored while new ones accumulate. The system you have today, including the history it carries, is what an inspector will evaluate. ## Where IVD Manufacturers Fit In The QMSR applies to finished device manufacturers intending to commercially distribute in the US, and that includes **in vitro diagnostics (IVD)**. For IVD developers, the shift raises its own questions, particularly for organisations that have historically maintained one quality system for FDA compliance and another aligned with ISO 13485 for international markets. There is a real upside here. ISO 13485:2016 is already recognised under the EU MDR and IVDR as meeting many quality management requirements. Manufacturers that built strong ISO-based systems for Europe therefore start with a solid foundation. However, a strong foundation is not the same as a finished one. The FDA-specific additions still need to be addressed explicitly, and differences in terminology, documentation, and regulatory expectations should be reconciled deliberately rather than assumed away. ## What to Prioritise Now ### Start With a Structured Gap Assessment Even if you believe your organisation is compliant, the first step should be a structured **gap assessment**. The objective is to confirm, with evidence, that your quality system satisfies both ISO 13485 and the FDA-specific requirements embedded within the QMSR. This is also the moment to determine which pre-February records can support compliance during future inspections. ### Make Risk-Based Thinking Visible The new inspection model expects risk management principles to be visible across the quality system. Risk should be integrated into: - Supplier controls - Design and verification activities - Software validation - Post-market surveillance It is not enough to maintain a risk file in isolation. ### Review Design Controls The QMSR preserves the FDA's design control requirements under 21 CFR 820.30. These requirements go beyond ISO 13485 clause 7.3 in several areas, particularly around design validation against user needs and the formality of design reviews. Design controls remain a recurring inspection focus. ### Review the FDA-Specific Layer Many ISO-certified organisations continue to find gaps in: - Labelling and packaging controls - Complaint handling - Servicing records - UDI requirements - Medical Device Reporting obligations These areas should be reviewed explicitly rather than assumed to be covered. ### Align Procedures With Practice One of the most common sources of findings remains the gap between documented procedures and actual practice. Enforcement rewards quality systems that are lived, not simply written. ## A Transition, Not a Finish Line The QMSR was never really about a single date. February 2, 2026 marked the start of a new operating reality for US medical device and IVD manufacturers, not the end of a project. The companies still searching for guidance are often the ones taking the regulation seriously enough to recognise that compliance is an ongoing state rather than a box to tick. That is a healthy instinct. Handled well, the QMSR provides an opportunity to modernise a quality system, eliminate duplicated documentation, and align more closely with global quality frameworks. The work that felt like a deadline scramble can become the foundation for a leaner, more resilient organisation. --- Source: https://qbdgroup.com/en/blog/qmsr-deadline-passed-still-searching-guidance — © QbD Group. Quote freely with attribution and a link back.