April 29, 2026

Did You Know? The QMSR Also Applies to Drug Device Combination Manufacturers

As medical products grow increasingly complex, the regulatory expectations for quality management systems must evolve as well. In February 2026, the US Food and Drug Administration (FDA) enacted the Quality Management System Regulation (QMSR), updating and modernizing its long-standing medical device quality management system requirements. But what does this mean for drug device combination manufacturers – companies that make products combining drug and device components (e.g., prefilled drug delivery systems, combination inhalers, drug-coated devices, etc.)?

Short answer: The QMSR applies to drug device combination product manufacturers specifically on the device component side. FDA itself clarified this in official rulemaking and compliance guidance.

What Is the QMSR?

The QMSR is a revised version of FDA’s quality management system requirements for medical devices. It replaces the older Quality System Regulation (QSR) and incorporates by reference the internationally accepted standard ISO 13485:2016, a globally recognized quality management system framework for medical device manufacturers. One detail to note: the QMSR is a completely new version of the same Part 820 in the Code of Federal Regulations – same reference (21 CFR Part 820), all new content.

The QMSR became effective on February 2, 2026, and fundamentally harmonizes FDA device quality management system expectations with global standards.

FDA’s Clarification for Drug Device Combination Products

When FDA finalized the QMSR, it also addressed the requirements for drug device combination products.

In the regulatory preamble published with the final rule, FDA explicitly stated that it made “conforming edits to Part 4 (21 CFR Part 4)” – the section of the regulation that defines quality management system requirements for drug device combination products – to clarify how device quality management system requirements apply.

Importantly, FDA clarified that the conforming edits “do not impact the Current Good Manufacturing Practice (CGMP) requirements for drug device combination products.”

This statement may sound counterintuitive, but here’s what it means:

Device quality management system requirements (now QMSR) continue to apply to the device constituent part of drug device combination products.
FDA did not eliminate these quality management system requirements, it simply aligned them with the upgraded QMSR framework.
Drug and biologic CGMP requirements (e.g., 21 CFR 211) remain separate and unaffected by the QMSR change.

So Why Does the QMSR Matter for Drug Device Combination Products?

Even if a product’s primary regulated activity is a drug or biologic, many combination products include a device component that is critical to safety and effectiveness, such as a prefilled syringe, an inhaler, or a wearable patch.

Based on the details FDA has provided on the new inspection requirements and FDA implementation guidance CP7382.850:

The QMSR applies to the device constituent part of a drug device combination product.
FDA has moved away from the old QSIT and to an updated device inspection program (CP 7382.850). The new program now uses ISO 13485-aligned techniques that will be applied when inspecting device quality management systems, including device components of drug device combination products.
Some drug device combination product manufacturers mistakenly assume the QMSR doesn’t apply to them, but regulatory compliance frameworks explicitly reference the QMSR for any product containing a medical device component.

In other words: If your product includes a device part subject to FDA device regulation, the QMSR expectations apply to that part of your quality management system.

What FDA Expects – Key Points

Here’s how FDA has made its expectations clear:

The QMSR applies to finished devices. The QMSR explicitly applies to “finished device manufacturers who intend to commercially distribute medical devices.” A finished device includes device components incorporated into drug device combination products.
ISO 13485 is incorporated. Because it incorporates ISO 13485:2016 by reference, the QMSR harmonizes US requirements with international expectations and emphasizes risk-based processes, lifecycle controls, and supplier management. This means that regardless of whether the device is a stand-alone product or part of a drug device combination, quality management systems must demonstrate alignment with global quality management principles.
Expanded inspection authority. Under the QMSR, FDA inspectors may review a broader set of quality records – including management reviews, supplier audits, and risk management documents – when evaluating compliance. For drug device combination product manufacturers, this translates to a greater emphasis on traceable documentation and demonstrable control of the device component throughout the product lifecycle.
Device CGMP requirements remain intact. The QMSR does not alter or eliminate device GMP requirements for drug device combination products; instead, it clarifies and harmonizes them to align with global practices.

What This Means in Practice

For manufacturers of drug device combinations, FDA’s framework implies:

Medical device constituent parts are subject to QMSR expectations, even if the product also meets drug or biologic regulatory pathways.
The QMSR requires a risk-based quality management system aligned with ISO 13485 principles, including documented design controls, risk management, supplier oversight, complaint handling, CAPA, and feedback.
FDA inspectors will use QMSR/ISO 13485-aligned methods when evaluating drug device combination product systems under the device constituent part.
Simply having a drug CGMP system (21 CFR 211) does not satisfy device quality expectations for the device part; both aspects must be controlled appropriately.
FDA inspectors will have access to internal audits and management review, and may ask for them as part of the QMSR, similar to the Notified Bodies for your medical device constituent part.

Conclusion

While the QMSR does not expand device GMP requirements to drug processes, it clearly continues to apply to any product with a regulated device component, including drug device combination products. FDA’s own incorporation of ISO 13485 into US requirements underscores that risk-based quality controls, thorough documentation, and a mature quality management system are essential – regardless of product type – when there is a device component.

Drug device combination product manufacturers should therefore not consider the QMSR optional. Instead, they must understand how it interfaces with other regulatory expectations, and ensure that their device quality management system aligns fully with the QMSR and the incorporated requirements of ISO 13485.

ELIQUENT supports medical device and drug device manufacturers at every stage of this transition, combining regulatory depth with hands-on inspection experience.
For organizations looking to build awareness and alignment quickly, ELIQUENT offers a 1-day FDA QSR to QMSR Transition Training class designed to help teams understand what is changing, what is not, and how inspection expectations are evolving.

For teams seeking a deeper, system-level understanding, ELIQUENT’s 3-day QMS, ISO 13485, and FDA QMSR Training course provides comprehensive instruction on building and sustaining an integrated, inspection-ready quality management system.

Beyond training, ELIQUENT provides quality management system audit and consulting services to help organizations assess QMSR readiness, prepare for FDA inspections, and strengthen quality management system effectiveness before, during, and after an inspection.

Whether you are just starting your QMSR transition or preparing for an upcoming FDA inspection under the new inspection approach, ELIQUENT can partner with your team to turn regulatory change into practical, sustainable improvement.

This article reflects ELIQUENT Life Sciences’ interpretation and application of publicly available FDA regulations and inspection frameworks, informed by extensive hands-on inspection and quality management system experience.

References

From QSR to QMSR: What’s Changing and Why It Matters
https://eliquent.com/qmsr-resources/
It’s Here! FDA QSR vs. QMSR: What Medical Device Manufacturers Need to Know
https://www.orielstat.com/blog/fda-qsr-vs-qmsr/
FDA Inspection of Medical Device Manufacturers Compliance Program
https://www.fda.gov/media/80195/download
Reference CP7382.850 Inspection of Medical Device Manufacturers
https://www.fda.gov/media/80195/download

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The European Commission’s proposal is a response to device shortages, innovation flight, and SME attrition, but its deeper intent is stability. Regulators are signaling that predictable manufacturers deserve predictable regulation. Those who internalize this shift will:

Spend less on recertification
Launch faster
Retain products in the EU market
Build durable trust with Notified Bodies

Those who treat this as merely a compliance simplification exercise will miss the deeper competitive inflection.

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