The medical device industry is counting down to an important deadline: On Feb. 2, 2026, the U.S. Food and Drug Administration’s new Quality Management System Regulation (QMSR) formally replaces the Quality System Regulation (QSR).

Although the full text of the QMSR has been available for some time, there are still questions around inspections under QMSR. The FDA is retiring the Quality System Inspection Technique (QSIT) document that was the guide to inspections under QSR. Given that the FDA has stated there will be no “QSIT 2.0,” there has been some confusion around what inspections will look like under QMSR.

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