FDA did not simply stop using QSIT. On February 2, 2026 — the same day the QMSR took effect — the agency retired two inspection manuals at once, Inspection of Medical Device Manufacturers (CP 7382.845) and the PMA inspection program (CP 7383.001), and replaced them with a single compliance program built around a structure most device quality teams have not yet mapped their audit programs against.

What actually changed

QSIT organized a quarter-century of device inspections around four subsystems, audited largely as separate checkpoints: Management Controls, Design Controls, CAPA, and Production & Process Controls. An investigator could clear Design Controls and move on without formally carrying an open thread into CAPA. CP 7382.850 was built for a different regulation — the QMSR's ISO 13485-based structure doesn't organize itself into QSIT's four boxes, so FDA didn't try to force it. It replaced the subsystem model with six QMS areas and layered four OAFRs on top, then instructed investigators to work the product's life cycle as one connected assessment rather than four separate ones.

Feb 2, 2026
CP 7382.850 took effect — retiring CP 7382.845 and CP 7383.001, not just the QSIT technique.
6 + 4
Six QMS areas plus four Other Applicable FDA Requirements replace QSIT's four subsystems.
TPLC
Total Product Life Cycle — design, production, and post-market data assessed as one thread, not four.

The six QMS areas — and the four OAFRs beside them

The subsystem-to-area mapping is not one-to-one, which is exactly where an audit program built on QSIT muscle memory falls short. CP 7382.850 organizes inspection emphasis into six QMS areas:

  • Change Control. Not a QSIT subsystem on its own — previously scattered across Design Controls and CAPA evidence.
  • Design and Development. The closest carryover from QSIT's Design Controls, now read forward into production and post-market data rather than closed out on its own.
  • Management Oversight. The successor to Management Controls, still the area that sets whether the rest of the system is credible.
  • Measurement, Analysis, and Improvement. CAPA's successor, broadened to the data and metrics that should have triggered a CAPA in the first place.
  • Outsourcing and Purchasing. Supplier controls, elevated to their own area rather than a line item inside Production & Process Controls.
  • Production and Service Provision. QSIT's Production & Process Controls, retitled to match the standard's own vocabulary.
The four Other Applicable FDA Requirements (OAFRs)
  1. Medical Device Reporting (MDR). Reportability decisions FDA now expects investigators to trace directly into the QMS areas above — see how the 5-day/30-day reportability clock feeds this.
  2. Corrections and Removals. Field actions reviewed alongside the CAPA and complaint data that triggered them, not as a standalone file.
  3. Tracking. Device tracking obligations, where they apply, folded into the same life-cycle read.
  4. UDI. Unique device identification data checked against the same design and production records — a gap this site has covered on the EU side and now sees mirrored in a US inspection context.
QSIT asked whether each subsystem passed. CP 7382.850 asks whether a finding in one area was ever going to surface in another — and whether your quality system would have caught that on its own. Why the life-cycle model changes exposure

What Total Product Life Cycle integration means for your next inspection

The practical exposure isn't the renamed areas — it's that a finding no longer stays inside the box where it was found. Under QSIT, a Design Controls observation and a CAPA observation could sit in separate sections of the inspection report, each closed on its own evidence. Under a life-cycle model, an investigator working Measurement, Analysis, and Improvement has an explicit mandate to ask whether a complaint trend should have shown up as a Design and Development signal months earlier. Teams that have only translated QSIT's vocabulary into the new area names — without rebuilding the cross-references between them — will pass a tabletop review of the new program and still be exposed on the thing it was built to catch. This is also where quality-system operating-model questions resurface: who owns a finding once it crosses from one QMS area into another, and how would your team know before an investigator does.

A CP 7382.850 readiness sequence you can run this quarter
  1. Map your subsystem checklist onto the new structure. Cross-reference Management Controls / Design Controls / CAPA / Production & Process Controls against the six QMS areas and four OAFRs.
  2. Trace linkages, not just subsystems. Build the cross-references from design decisions to CAPA, complaints, and MDR data that a life-cycle inspection now follows as one thread.
  3. Confirm your MDSAP posture. Know how MDSAP findings feed the new picture, and where a for-cause or pre-approval inspection still applies regardless.
  4. Mock-inspect against the new structure. Rehearse the six-area, four-OAFR model directly, and let the findings — not a QSIT script in new labels — drive remediation.

None of this requires rebuilding your quality system from scratch. It requires re-reading your existing audit program against a structure that crosses old boundaries on purpose, then proving the cross-references hold up under questioning. Companies that ran a mock FDA inspection built on the retired QSIT script will find the new format unforgiving in exactly the places their old rehearsal never looked; companies that treat inspection readiness as a life-cycle question, not a subsystem checklist, are the ones the new program quietly rewards. If your team has not run this mapping since the effective date, that is the place to start.

Frequently asked questions

What replaced QSIT for FDA device inspections?

Compliance Program 7382.850, effective February 2, 2026 alongside the QMSR. It replaces CP 7382.845 and the PMA inspection program CP 7383.001, moving from QSIT's four-subsystem model to a Total Product Life Cycle approach that ties design, production, and post-market data into one assessment.

What are the six QMS areas under CP 7382.850?

Change Control, Design and Development, Management Oversight, Measurement Analysis and Improvement, Outsourcing and Purchasing, and Production and Service Provision — plus four Other Applicable FDA Requirements: Medical Device Reporting, Corrections and Removals, Tracking, and UDI.

Does MDSAP participation still matter under CP 7382.850?

Yes. FDA continues to accept MDSAP audit reports in place of routine surveillance inspections, and the new program folds those findings into its broader compliance picture. MDSAP was never a substitute for for-cause or pre-approval inspections, and that has not changed.

Sources & further reading

  1. FDA. Town Hall: FDA's Quality Management System Regulation (QMSR) — Medical Device Risk-Based Inspections. fda.gov
  2. FDA. Center for Devices and Radiological Health (CDRH) Compliance Programs. fda.gov
  3. FDA. Medical Devices; Quality System Regulation Amendments — Final Rule (89 FR 7496, Feb 2, 2024). federalregister.gov

This article is provided for general informational purposes and reflects the regulatory landscape as of September 2026. It is not legal or regulatory advice. Confirm current FDA compliance-program details and inspection-program announcements with FDA or qualified counsel before your next inspection.