What QMSR means for labs using incubators
Adam Hartmann-Kruckow
The FDA's Quality Management System Regulation (QMSR) took effect February 2, 2026. For labs running incubators in GxP-regulated processes, here is what actually changed and the practical question it raises about your current monitoring setup.
What is QMSR?
The Quality Management System Regulation (QMSR) is the FDA's updated quality system framework for medical device manufacturers. It replaces the old Quality System Regulation (QSR), which had not been substantially revised since 1996.
The core change: QMSR incorporates ISO 13485:2016 by reference. That means the FDA's quality requirements for medical device manufacturers now align with the international standard used in the EU, Canada, Japan, and most other major markets. If you were already certified to ISO 13485, you are closer to compliant than companies that were only following the old QSR, but not automatically there.
QMSR applies to medical device manufacturers, which includes companies that design, manufacture, package, label, store, install, or service finished medical devices marketed in the US. Incubators used in regulated applications such as cell culture, microbiology testing, and in vitro diagnostics fall into this category.
Also read: Key regulations of temperature compliance
What changed for incubator compliance on February 2, 2026?
Two regulatory shifts happened in close succession, and understanding both matters for labs using incubators.
QMSR took effect. The FDA began enforcing the new quality management framework for medical device manufacturers. The headline change is the shift from prescriptive checklists to risk-based thinking: for every critical process parameter, manufacturers must demonstrate that risk was identified, assessed, monitored, and controlled with documented evidence throughout.
Practically, this means several things that were previously best practices are now explicit requirements:
- Traceability: Documented links between design inputs, design outputs, verification testing, and validation are now required. Under the old QSR, this was considered best practice.
- Internal audit visibility: Under the old QSR, FDA investigators could not inspect management review records, internal audit reports, or supplier audit records. Under QMSR, that exemption is gone. Those documents are now fair game during an FDA inspection.
- Risk integration throughout the QMS: The word "risk" appears more than 25 times in ISO 13485. In the old QSR, it appeared once. Risk-based thinking is no longer confined to design controls. It runs through supplier management, manufacturing processes, post-market activities, and monitoring.
The FDA's Laboratory-Developed Test (LDT) rule was struck down and rescinded. In March 2025, a federal court vacated the FDA's rule that would have regulated laboratory-developed tests as medical devices. The FDA formally rescinded the rule in September 2025. The practical consequence: the FDA can no longer regulate the lab test itself as a device. What it can regulate more directly is the hardware used to run those processes. Incubator manufacturers face heightened scrutiny to demonstrate their devices meet QMSR.
What does QMSR mean for labs using incubators?
Incubators are classified as medical devices, which means the manufacturers who make them are subject to QMSR. The implications for labs using incubators follow from the same risk-based logic.
If your lab uses incubators in a GxP-regulated process, QMSR's framework raises a direct question: does your current compliance program produce the kind of documented, traceable evidence that demonstrates active control of critical process parameters?
Under the old QSR, qualifying your incubator — running IQ/OQ/PQ — and maintaining calibrated sensors was the primary focus. QMSR does not remove those requirements. But it adds explicit emphasis on risk-based documentation: you need to show not just that your incubator was qualified, but that critical parameters are actively monitored and that your evidence is traceable and audit-ready throughout operation.
For most labs, the qualification and calibration side is already solid. The area that warrants a closer look is monitoring — specifically, whether your monitoring setup produces the continuous, traceable, tamper-evident records that QMSR's risk documentation expectations imply.
Is your incubator monitoring QMSR-ready?
Use the free gap checklist to find out, covering QMS scope, equipment qualification, monitoring, calibration, documentation, and supplier controls.
What evidence does QMSR expect from your incubator monitoring?
Here is where the implications become concrete.
Many incubators used in regulated applications have a built-in temperature control probe. That probe maintains the chamber at the setpoint. It was designed and calibrated to do that job, and it does it well. But it was designed to maintain temperature, not to serve as your compliance record.
If your process has a critical temperature ceiling – for example, mammalian cell cultures used in cell and gene therapy research must not exceed 37°C (98.6°F), because exceeding human body temperature can cause certain growth that invalidates a batch – then you need documented, traceable evidence that the limit was not exceeded during each run.
The question QMSR's risk framework raises is: can your current monitoring setup provide that evidence? Is the data continuous, calibrated, audit-ready, and tied to a Part 11/Annex 11-compliant system? Or is it a periodic manual check, or reliance on the incubator's own readout?
This is not a new compliance requirement invented by QMSR. The underlying expectation that critical process parameters must be monitored with traceable, reliable data is consistent with GMP principles that have applied for years. What QMSR does is make the risk-based framing explicit and remove the ambiguity about what "adequate evidence" looks like.
If your current monitoring setup would not hold up when an auditor asks "show me the documented evidence that temperature stayed within your critical limits during this batch," that is the gap worth closing.
Secure the independent monitoring QMSR expects
With continuous incubator monitoring for GLP and GMP
- ISO 17025-accredited calibration included
- Continuous, audit-ready records out of the box
- 21 CFR Part 11/Annex 11-ready platform
