In Vitro Diagnostics: Preparing for an FDA Inspection Under QMSR
IVD inspection preparation should use the current QMSR framework and the requirements that apply to the product, manufacturing activities, labeling, and postmarket controls.
Start with the current regulatory framework
QMSR became effective on February 2, 2026. FDA replaced QSIT with the inspection process described in its updated medical-device manufacturers compliance program. A current readiness plan should not present the former QSR section numbers as if they were an unchanged present-day framework.
Identify the manufacturer’s activities and the requirements applicable to the particular device. FDA’s QMSR resources and FAQs are the starting points for the current quality-system framework. IVD labeling is separately addressed in Part 809. A quality-system review does not replace an assessment of the product’s intended use, classification, or applicable marketing requirements.
Trace the product through its records
Select an actual product configuration and follow the relationship between requirements, production evidence, release information, labeling, and postmarket information. This is a suggested readiness exercise; it is not an FDA-mandated universal audit sequence.
- Confirm the intended use and current label or instructions.
- Trace relevant reagent, kit, and component identifiers into production history.
- Locate the records supporting release and any relevant deviations.
- Review how complaints and corrective actions connect to the product.
- Identify the records and people needed to explain outsourced activities.
Prepare record owners and the inspection team
Assign people who can explain the processes they perform and locate the associated evidence. A request log can help track what was requested, who is retrieving it, and what was provided. Keep answers factual. If the team does not know an answer, find the appropriate person or record rather than guessing.
Do not change, backdate, or recreate records to make them appear contemporaneous. Where a correction or follow-up is necessary, preserve its context through the applicable controls. A mock inspection should identify preparation gaps and support corrective work, rather than promise a particular FDA outcome.
Review management and audit records under QMSR
FDA states that management-review, quality-audit, and supplier-audit reports are inspectable under QMSR. The former exceptions in section 820.180(c) were not retained. FDA also says records created before the effective date may be reviewed to assess current compliance. Prepare the relevant records and their documented follow-up; do not assume an ISO certificate prevents FDA inspection.
Keep RUO and other product boundaries clear
For products represented as research use only or investigational use only, evaluate the actual intended use and presentation against the relevant FDA guidance. A label statement should not be treated as the entire regulatory analysis. Do not use an obsolete LDT phaseout schedule as a substitute for checking the current position applicable to the operation.
Respond accurately if observations are issued
Form FDA 483 observations are not a final agency determination. At closeout, seek to understand the observations and clarify factual questions. FDA encourages a written response describing corrective action. Confirm any applicable timing with the actual FDA correspondence and relevant policy; do not characterize every 483 as creating a universal statutory 15-business-day response obligation.
A useful response plan identifies the reviewed scope, investigation work, actions, responsible people, evidence already available, and realistic completion dates. Do not claim completion without support or assume that submission of a response guarantees that no further agency action will occur.
Related inspection resources
Primary sources
- FDA: Quality Management System Regulation
- FDA: QMSR frequently asked questions
- FDA: IVD labeling requirements
- FDA: RUO and IUO IVD distribution guidance
- FDA: Form 483 frequently asked questions
Sources reviewed October 20, 2026. The preparation steps above are practical suggestions; the linked regulations and FDA documents define the applicable requirements.