FDA Medical Device Inspections in 2026: Preparing for the New QMSR Framework

For medical-device manufacturers, 2026 brings practical regulatory changes that should be translated into clear actions across quality, regulatory and operational teams.

QSIT has been replaced

Beginning February 2, 2026, FDA stopped using the Quality System Inspection Technique (QSIT) for medical-device inspections. Inspections are now conducted using the updated Inspection of Medical Device Manufacturers Compliance Program, CP 7382.850, which aligns the inspection process with the QMSR.

Expect a system-level assessment

The best preparation is a QMS that works consistently in practice. Investigators may evaluate whether procedures are implemented, whether records support the claimed process, and whether quality issues are identified, investigated and corrected appropriately. A polished SOP without matching evidence can create greater scrutiny rather than confidence.

More records may be available for review

FDA’s QMSR FAQ confirms that investigators may review records created before February 2, 2026 when determining compliance. Importantly, the QMSR no longer maintains the prior inspection exemptions for management-review, quality-audit and supplier-audit reports. Companies should therefore ensure these records are complete, controlled and suitable for regulatory review.

Inspection-readiness checklist

Maintain current organizational and facility information; ensure requested records can be retrieved promptly; verify CAPA, complaint, nonconformance and supplier-control files for consistency; confirm design and development records are traceable where applicable; review management-review and internal-audit outputs; verify training records; assess risk-management linkages; and conduct a realistic mock inspection using representative records.

Prepare people as well as documents

Subject-matter experts should understand their processes and be able to explain them clearly and accurately. Responses should be factual, concise and supported by records. Teams should know how inspection requests are logged, who approves document release, how copies are controlled and how emerging observations are escalated internally.

Use the transition as an improvement opportunity

The change from QSIT to the QMSR-aligned inspection process is an opportunity to reduce fragmented compliance practices. Organizations that integrate ISO 13485 principles, FDA-specific requirements and risk-based quality management into one coherent system will be better positioned for both inspections and routine operations.