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Does ISO 13485 certification or a Notified Body audit mean we’re ready for a QMSR Inspection?
No. ISO 13485 certification and Notified Body audits may help identify gaps, but they do not replace QMSR readiness activities or the manufacturer’s internal audit obligations. FDA-specific requirements, including the four OAFRs — MDR, Corrections & Removals, Tracking, and UDI — must be separately verified. Manufacturers should perform a targeted QMSR gap assessment and may use Notified Body audit findings to inform internal audit planning, identify areas for deeper review, and strengthen the internal audit program.
We passed our last inspection under QSIT. Does that mean we’re in good shape?
Not necessarily. A clean QSIT inspection reflected compliance with the four major subsystems under the legacy QSR model. It does not demonstrate whether your:
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management review records are adequate;
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internal audits reflect genuine system assessment;
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risk management is applied beyond design controls;
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supplier controls are risk-proportionate; and/or
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UDI and MDR documentation meet current standards
A gap assessment against CP 7382.850 elements is the most reliable way to assess your readiness.
What is the difference between a for-cause inspection and a surveillance inspection under the new framework?
A for-cause inspection begins with a defined risk-signal, such as an MDR cluster, recall, or trade complaint – investigators trace that signal through the QMS. Both for-cause and non-baseline inspections follow Model 1 (minimum 1 element per QMSR area), but for-cause inspections have a focused starting point. Surveillance inspections begin with a broader QMSR scan. Both inspection types can expand in scope based on the investigator’s findings.
What does a Remote Regulatory Assessment look like in practice?
FDA sends a formal records request under FD&C Act 704(a)(4). You must respond within the stated timeframe – typically days, rather than weeks. Documents are transmitted electronically. Investigators review them remotely and may issue 483 observations based on that review alone, or may follow up with an on-site visit. The records requested may cover any QMSR Area or OAFR.
How does CP 7382.850 affect manufacturers who are seeking a PMA?
CP 7382.850 consolidates PMA and routine inspection programs. PMA preapproval inspections follow Model 2 (comprehensive, 22+ elements), while PMA post-market inspections follow Model 1. Supplier audit reports and quality agreement content with contract manufacturers may also be reviewed during inspection.
Will FDA review management review, internal audit, and supplier audit records under QMSR?
Yes. Records that were previously excluded from routine FDA inspection under 21 CFR 820.180(c), including management review, internal audit, and supplier audit records, may now be reviewed under Compliance Program 7382.850. These processes are expected to be reviewed during baseline surveillance and premarket pre-approval inspections and may be reviewed in other inspections depending on the inspection focus. Manufacturers should treat these records as FDA-facing documents and ensure they are accurate, complete, and aligned with their QMS procedures.
Are records created before February 2, 2026, expected to meet QMSR requirements?
No. Manufacturers do not need to revise or recreate records created before February 2, 2026, to align with QMSR requirements or ISO 13485 terminology. However, if review of historical records identifies gaps in the quality management system, those gaps should be addressed.
How will FDA investigators decide which records and QMS elements to review?
Investigators will not rely on a statistical sampling plan. Instead, they will review records and QMS elements based on product risk, inspection findings, and professional judgment. Both inspection models define minimum elements that must be reviewed, but investigators may examine additional records or QMS elements when needed to evaluate compliance or understand how the manufacturer identifies and controls risk. This is part of FDA’s normal risk-based inspection approach and should not automatically be viewed as an expansion of scope.
How will FDA assess quality culture and leadership accountability?
FDA will assess quality culture by reviewing how the manufacturer makes decisions and operates its quality management system. Investigators may look for evidence that leadership supports quality, uses risk-based decision-making, addresses quality issues effectively, and prioritizes patient and user safety across the organization.
How will FDA apply risk-based expectations to administrative processes such as document control and training?
FDA expects a risk-based approach for all QMS processes, including administrative processes. Manufacturers do not need separate formal risk files for every administrative process, but decisions should be based on product risk, process impact, and existing risk management information. For training, FDA will assess whether the method used to evaluate effectiveness is appropriate for the risk of the activity. Higher-risk processes may require stronger evidence, such as skill assessments, supervisor evaluations, practical demonstrations, or performance monitoring, while lower-risk activities may support simpler verification methods.
Has the threshold for FDA compliance action changed with QMSR implementation?
No. The threshold for compliance action has not changed. FDA’s inspection framework has been updated to align with QMSR and its risk-based approach, but FDA will continue to take compliance action when necessary to protect public health.
Conclusion
For manufacturers, these changes require closer attention to how processes are implemented, how records support decisions, and how risk is identified and managed across the organization. Areas that were once considered secondary in routine inspections are now more likely to be reviewed in context, based on risk and inspection findings.
Taking a structured approach to assessing, these elements and addressing gaps where identified, can help organizations better understand their current level of readiness and respond more effectively to this evolving inspection approach.
*Make sure to visit our blog in the coming weeks: a technical ebook on how inspections have evolved will be available.*
