On Feb. 2, 2026, the Food and Drug Administration (FDA) officially sunset the longstanding Quality System Regulation (QSR) and its companion inspectional guide, the Quality System Inspection Technique (QSIT). In their place stands the new Quality Management System Regulation (QMSR) and revised Compliance Program Manual (CPM) 7382.850 for the inspection of MedTech manufacturers.
This was an important step forward to align US medical device requirements with international quality systems standard ISO 13485:2016 and streamline expectations of device makers worldwide.
Regulatory modernization isn’t a problem, but the lack of inspectional clarity may be.
QSIT functioned as the de facto roadmap for device inspections for 27 years. Implemented in 1999 by an FDA team led by QualityHub Founder and President Tim Wells, QSIT did something profoundly important for both facility investigators and industry: it made the inspection process transparent. It laid out how inspections would flow, what subsystems would be emphasized, and how compliance would be evaluated in sequence. It reduced ambiguity.
MedTech manufacturers have become so accustomed to having QSIT as a resource and guide that its absence has already been felt by some in industry.
The updated CPM for device inspections, however, doesn’t provide that same transparency industry has grown accustomed to. The CPM now outlines six core elements investigators will evaluate, including:
- Change Control,
- Design and Development,
- Management Oversight,
- Measurement, Analysis, and Improvement,
- Production and Service Provision, and
- Outsourcing and Purchasing.
These elements aren’t controversial or unknown. They are foundational pillars of any quality management system.
What is missing is the inspectional structure. What is needed is predictability and transparency of the FDA’s approach for evaluating compliance.
QSIT Was More Than a Checklist
QSIT wasn’t merely a summary of requirements. It provided a subsystem-based inspection model. It described sampling logic, explained inspectional sequencing, and told manufacturers, in practical terms, how investigators would approach:
- Management Controls,
- Design Controls,
- Corrective and Preventive Action (CAPA), and
- Production and Process Controls.
In short, it operationalized the regulation.
Even when companies disagreed with enforcement outcomes, they generally understood the inspection framework. That predictability reduced friction and improved preparation. It fostered alignment around expectations.
The FDA’s recently updated CPM, by contrast, identifies broad system areas but doesn’t provide comparable procedural clarity. While it provides a high-level description of inspection types and which inspection model will be applied, it lacks the roadmap investigators and industry have become accustomed to. Without it, variability will exist in how facility inspections may be conducted across FDA districts and investigators.
For an industry built on risk management and predictability, that isn’t trivial.
Transparency: A Compliance Tool
The FDA indicated in April 2025 that it doesn’t intend to develop a “QSIT 2.” That position is understandable in the context of regulatory modernization and the agency’s resource constraints.
Importantly, QSIT wasn’t implemented immediately upon the release of the now-retired QSR; rather, the structured inspection approach was released two years after the former rule came into force. With industry now in a similar transition moment, that historical precedent strengthens the argument for a new inspection guide.
The QMSR aligns with ISO 13485, but ISO audits aren’t FDA inspections. They differ in authority, documentation expectations, evidentiary standards, and enforcement implications. Without an inspection technique guide, industry is left to infer how FDA investigators will translate ISO-aligned clauses into inspectional practice.
That ambiguity increases regulatory risk while potentially compromising product quality and patient safety.
A superficial framework, even one listing six elements as the FDA’s updated CPM does, invites variability. Some investigators may conduct deep design sampling. Others may focus heavily on supplier controls. Still others may emphasize management review documentation.
Without a standardized inspection technique, consistency may erode.
For companies operating across multiple sites, or for those preparing for first-time FDA inspections under the QMSR, this uncertainty creates:
- Over-preparation in some areas;
- Under-preparation in others;
- Increased anxiety and resource diversion; and
- Heightened enforcement unpredictability.
None of these outcomes serve the public health.
Why Industry Should Be Vocal
Regulatory predictability isn’t a request for leniency; it’s a request for clarity. It should also not be interpreted as criticism, but rather a plea to partner on shared public health goals.
The MedTech industry should collectively and constructively advocate for the development of an updated inspection guide aligned with the QMSR. Not a nostalgic reissue of QSIT, but a modernized inspection framework that:
- Explains inspection sequencing;
- Clarifies sampling logic;
- Defines expectations for objective evidence; and
- Aligns ISO language with FDA enforcement authority.
The FDA has historically responded to stakeholder engagement when such engagement is thoughtful and centered on patients.
A new structured inspection technique would heighten compliance, reduce inspection variability, strengthen alignment between FDA inspections and ISO audits, and ultimately boost patient safety.
Modernization Requires Structure
The FDA’s regulatory modernization and harmonization by way of the QMSR is strategically sound. But harmonization doesn’t eliminate the need for inspectional transparency.
The sunset of QSIT leaves a gap and the agency’s CPM, as currently structured, doesn’t fully fill it. Regulation without inspection clarity is incomplete.
Stakeholders should contact the FDA today and let the agency know a new inspectional approach is needed to replace QSIT, which worked wonderfully for 27 years.
If the FDA doesn’t intend to publish a “QSIT 2,” it should nevertheless provide an inspection technique framework under another name.
The FDA didn’t develop QSIT immediately when the QSR was finalized, but the agency did start work on the inspectional approach when the need for it became evident. That need for a comprehensive approach still exists for many. MedTech manufacturers have become so accustomed to having QSIT as a resource and guide that its absence has already been felt by some.
And this time, industry shouldn’t wait in silence and hope for one to emerge. Stakeholders should contact the FDA today and let the agency know a new inspectional approach is needed to replace QSIT, which worked wonderfully for 27 years.
