CP 7382.850 vs. QSIT: How FDA Device Inspections Changed in 2026

CP 7382.850 is FDA’s compliance program for inspecting medical-device manufacturers under the Quality Management System Regulation (QMSR). QSIT—the Quality System Inspection Technique—was the previous inspection approach used with the former Quality System Regulation. The important 2026 change is not simply a new checklist: manufacturers must prepare evidence against the current regulatory framework and the current inspection program.

QMSR became effective February 2, 2026, incorporating ISO 13485:2016 by reference while retaining FDA-specific requirements. FDA’s QMSR overview explains the discontinuation of QSIT and use of the updated inspection process. A legacy QSIT preparation binder may contain valuable records, but its organization should not be mistaken for a complete map of current requirements.

Regulation, standard and inspection program are different things

QMSR establishes regulatory requirements. ISO 13485 provides the incorporated quality-system framework, subject to FDA’s provisions. CP 7382.850 gives FDA personnel instructions for inspections. These sources interact, but an inspection-program heading is not itself a substitute for identifying the applicable regulatory requirement.

That distinction prevents two errors. First, checking every line in an internal inspection worksheet does not prove compliance. Second, assuming an ISO certificate ends the FDA inquiry overlooks the agency’s own requirements and inspection authority. Our QMSR complete guide provides the implementation context behind the comparison.

Move from familiar subsystems to current QMS areas

Historical QSIT preparation emphasized major subsystems such as management controls, design controls, corrective and preventive action, and production and process controls. Those concepts remain operationally relevant, but CP 7382.850 organizes its inspection instructions into six QMS areas: Change Control; Design and Development; Management Oversight; Measurement, Analysis, and Improvement; Outsourcing and Purchasing; and Production and Service Provision.

The program also identifies four Other Applicable FDA Requirements: Medical Device Reporting, Corrections and Removals, Medical Device Tracking, and Unique Device Identification. Determine applicability rather than treating every requirement as identical for every manufacturer. Registration, listing and marketing authorization obligations also remain separate matters to evaluate.

Do not build a one-to-one conversion chart that implies each old subsystem has a single new destination. A software change can connect design, risk, supplier controls, deployment and feedback. A complaint may reveal a production problem and initiate a design change. The evidence must support those connections regardless of how the records were previously filed.

A practical comparison—not an official equivalence table

This table is an editorial planning comparison. It does not establish legal equivalence between historical and current requirements, prescribe an FDA inspection sequence, or guarantee an inspection outcome.

Prepare an evidence trail for a digital-health release

Take an AI-enabled clinical application with a recent performance-related update. Start with the approved intended use and software configuration. Retrieve the change request, rationale, risk assessment and affected requirements. Show the verification and validation strategy, acceptance criteria, results, deviations and release authorization for that version.

Next, inspect interfaces. Did a supplier component change? Did deployment assumptions change? Were labeling or user instructions affected? Was the need for a new regulatory submission assessed separately? Can the responsible staff retrieve the relevant records without reconstructing the history during the inspection?

Finish with post-release feedback. Show how complaints and nonconformities are assessed, how reportability decisions are documented where applicable, and how corrective actions are followed through to effectiveness. The six QMS areas guide expands the inspection preparation questions for each area.

What to keep—and what to rebuild

Keep valid historical evidence, justified decisions and effective processes. The transition does not mean every record must be replaced or renamed. Preserve dates, revisions and context so records accurately represent what occurred. Never overwrite history to make a file appear contemporaneous with a newly adopted template.

Rebuild weak requirement maps, unsupported exclusions, missing interfaces and retrieval indexes. Review whether internal audit and management-review materials are maintained and available as required under the current framework; assumptions inherited from the old regulation should be reassessed against the final rule and current program.

For FDA-specific provisions, examine records and device labeling/packaging controls where applicable. Use our ISO 13485–QMSR gap analysis to distinguish incorporated ISO requirements from additional US requirements without reproducing copyrighted clause text.

A focused rehearsal checklist

• Confirm the current regulatory references and device/activity scope.
• Assign accountable owners across all applicable QMS areas.
• Trace one released device and one significant change through linked records.
• Sample critical outsourced activities and supplier acceptance evidence.
• Connect complaints, corrections and applicable reporting decisions.
• Record unresolved gaps, risk decisions and evidence-backed actions.

A rehearsal is most useful when it samples unfamiliar records rather than a polished showcase file. Measure whether reviewers can understand decisions and identify the correct approved evidence. A fast download of the wrong revision is not successful retrieval.

Keep the rehearsal record concise: sampled device, applicable requirement, evidence retrieved, unresolved question and responsible owner. Review disagreements between engineering, quality and operations before they become inconsistent explanations. The goal is not a rehearsed script for investigators, but a shared understanding of actual processes and documented decisions. Preserve unresolved questions honestly and track them to justified actions.

Download the preparation crosswalk

Download the QSIT-to-QMSR Inspection Preparation Crosswalk.xlsx. Use it to identify legacy preparation habits, current QMS areas, evidence samples, owners and unresolved actions. It is not an official FDA crosswalk and should not replace the program or applicable regulation.

If the exercise reveals process gaps, our 90-day implementation roadmap offers a risk-based planning sequence. Do not defer urgent controls while waiting for the next phase of that suggested schedule.

MedTech Copilot supports structuring requirements, quality, risk and V&V evidence into a reviewable workflow. Its role is to support expert decisions and traceable preparation, not to predict FDA findings or confer certification.

FDA primary sources

• FDA QMSR overview: transition from the former inspection approach.
• FDA Compliance Program 7382.850: six QMS areas, inspection instructions and Other Applicable FDA Requirements.
• FDA’s QMSR final rule, official Federal Register publication: regulatory rationale, incorporated framework and retained FDA provisions.