The introduction of the Quality Management System Regulation (QMSR) by the US Food and Drug Administration (FDA) on 2 February 2024 marks a pivotal change, as it updates the Quality Management Systems requirements under 21 CFR part 820 to closely align with the ISO 13485:2016 standard. This change represents a major transition for medical device manufacturers, necessitating swift action to adapt. The clock is ticking towards the 2 February 2026 deadline when these new regulations come into effect, leaving companies with a tight timeframe to update their Quality Management Systems to comply with the new requirements. We’ve broken down the critical changes for you and outlined the actions you need to take now.
Table of contents:
- What is the Quality Management System Regulation (QMSR)?
- What exactly does the QMSR change?
- Why manufacturers need to prepare for the QMSR now
- The FDA’s next steps
- Conclusion
What is the Quality Management System Regulation (QMSR)?
At its core, the QMSR is designed to align the FDA’s Quality Management System requirements with the globally recognized ISO 13485:2016 standard. Through the QMSR, the FDA is amending section 820 of 21 CFR, which governs the quality management system criteria for medical device companies. This new regulation replaces the old Quality System Regulation (QSR) and incorporates ISO 13485:2016 by reference, so that the guidelines in 21 CFR part 820 essentially mirror those in ISO 13485:2016.
The FDA’s 21 CFR part 820 has always closely matched the ISO 13485:2016 standards, making the formal shift to the Quality Management System Regulation (QMSR) a logical step. This change, proposed in 2022, aims to fully harmonise U.S. regulations with the global benchmark for medical device quality management systems. By aligning the existing Quality System Regulation (QSR) with ISO 13485, the FDA aims to streamline compliance for manufacturers and ensure that the US framework reflects the latest international quality standards.
However, the QMSR has modified some of the provisions of ISO 13485:2016 and requires manufacturers to comply with both regulatory frameworks.
What exactly does the Quality Management System Regulation change?
The QMSR updates the FDA’s expectations for Quality Management Systems to largely mirror those of ISO 13485:2016, with a few key differences. Here’s a rundown of the key changes.
Key Changes from the Final Rule
The QMSR introduces several significant changes focused on harmonisation and risk management:
- Risk-Based Decision Making: In a departure from previous regulations, the QMSR integrates risk management throughout the product lifecycle, promoting a forward-looking approach to quality assurance.
- Audit Transparency: This eliminates exemptions that previously kept management and audit reports off the FDA’s radar, signalling a move towards greater openness. The change, which mirrors the approach of the ISO standard, could influence the way internal audits are conducted.
- Terminology Updates: The QMSR updates certain terms, notably replacing “management with executive responsibility” with “top management” and moving from “device master record” (DMR) to the more comprehensive “medical device file”.
Incorporation by Reference
The new Section 820 of 21 CFR now incorporates ISO 13485:2016 “by reference”, indicating that the FDA considers the ISO standard’s requirements to be largely equivalent to its own. This puts manufacturers who follow the ISO standard in a good position.
However, the FDA has placed limits on this equivalence:
- Future versions of ISO 13485:2016 won’t be automatically incorporated. The FDA explicitly states that any future revisions will need to be evaluated to determine if changes to this rule are necessary.
- Adjusting ISO 13485:2016 to fit the FDA framework means not adopting it wholesale to prevent conflicts with other FDA regulations. As a result, some discrepancies and additional regulations will require manufacturers to comply.
ISO certifications alone won’t be sufficient for FDA oversight activities, such as inspections under section 704 of the FD&C Act or the preparation of an Establishment Inspection Report (EIR). Manufacturers already ISO 13485:2016 certified will still need to align their quality management systems with the specific requirements of the QMSR.
Deviations of the QMSR from ISO 13485:2016
The QMSR introduces stricter definitions, record keeping, labelling and traceability requirements to bridge areas not fully covered by ISO 13485.
Specifically, the QMSR differs from ISO 13485:2016 in the following ways:
Enhanced Definitions and Provisions
To avoid potential regulatory mismatches, the FDA has added new definitions and provisions to the QMSR. It clearly delineates additional terms like “Component”, “Finished Device”, and “Remanufacturer”, diverging from ISO 13485’s vocabulary. It also reinterprets terms such as “Implantable Medical Device” and “Manufacturer” to better suit the FDA’s regulatory framework. The QMSR also ensures that the terminology used for combination products is consistent with current Good Manufacturing Practice (CGMP) standards.
Additional Requirements of the QMSR
Although many of the requirements of ISO 13485 are recognised, the FDA emphasises that ISO compliance alone doesn’t fulfil the obligations of the QMSR. Key inclusions are:
- Control of Records: The QMSR requires strict control of certain records in accordance with the requirements of the FD&C Act. These include complaint and service records, as well as compliance with Medical Device Reporting and Unique Device Identification norms.
- Labelling, Packaging: Strengthens governance of labelling and packaging processes and addresses ISO 13485:2016 oversight of manufacturer label inspections.
- Unique Device Identification (UDI): Manufacturers must comply with detailed UDI regulations as outlined in section 830, improving product traceability.
Why manufacturers need to get ready for the Quality Management System Regulation now
The broad adoption of ISO 13485:2016 among medical device manufacturers raises the question: Why the rush to get ready for the QMSR? The transition from the QSR to the QMSR isn’t just a procedural update; it’s a major overhaul of compliance standards. Even though the QSR historically paralleled ISO 13485 in structure and intent, it wasn’t a carbon copy. The QMSR’s arrival brings substantial changes requiring a complete review and update of existing Quality Management Systems to ensure adherence to FDA guidelines by February 2026.
The crux of the matter lies in the QMSR’s departures from ISO 13485:2016. These variances mean manufacturers can’t solely depend on their existing ISO certifications to satisfy FDA criteria. The FDA has clarified that mere compliance with ISO 13485 won’t cut it; the agency will look for proof of meeting additional, specific QMSR requirements. This directive is a clear prompt for manufacturers to proactively refine their QMS to sync with the QMSR’s distinct requirements, extending beyond ISO 13485:2016’s scope.
Considering this backdrop, the urgency of prepping for the QMSR is clear. The 2026 deadline might seem far off, but the breadth and depth of the requisite modifications call for immediate action. Achieving compliance may entail more than minor tweaks, possibly requiring a full overhaul of certain processes and documentation to align with the new regulatory environment. This preparatory phase is critical for manufacturers aiming for a smooth transition and to maintain their FDA compliance in the dynamically changing medical device market.
Next Steps for the FDA
As 21 CFR part 820 evolves to align with ISO 13485:2016, the FDA is concentrating on several areas to ease this transition. These initiatives encompass updating IT systems, providing comprehensive training for staff on the new regulations and inspection methodologies, and revising relevant regulations and documents. A revamped inspection protocol is in the works to ensure alignment with the Quality Management System Regulation (QMSR) standards by February 2026. These updates will affect not just internal processes but also public-facing components like forms and IT systems, reflecting the revised regulatory vernacular. Given the significant shift from the longstanding QS regulations, the FDA is also poised to issue new guidance documents to clarify industry queries about QMSR implementation.
For those seeking more info, the FDA has set up a Frequently Asked Questions page.
Conclusion
The FDA’s latest amendments to 21 CFR part 820, bringing it closer to ISO 13485:2016, signify a crucial move towards global regulatory alignment. Yet, it’s imperative for manufacturers to acknowledge and adapt to the specific differences that distinguish the U.S. regulatory scene. With the 2026 deadline on the horizon, grasping and incorporating both global and U.S.-specific quality management system criteria is essential. The time to act is now – delaying preparation isn’t an option.
At Johner Institute New Zealand, we’re experts in QMS consultancy, ready to guide you through these updates. For professional advice on ensuring your compliance, feel free to reach out to us.
Keen to delve deeper into QMS? Consider joining our 12-month Quality Management Systems (QMS) course starting on 4 July. Here, you’ll master all you need to know about QMS requirements.
