FDA Inspections After QMSR: What Replaces QSIT 2.0 - The New Inspection Reality

Description

The US FDA, a has finally published their QMSR to replace the previous QSR. Implementation deadline is  February 02, 2026. The Quality Management System Regulation (QMSR) revises 21 CFR 820 to include ISO 13485:2016 (and ISO 9000 Clause 3) by reference.  For FDA inspections, no QSIT 2.0 on the way.  Instead, FDA inspections will transition to a process aligned with ISO 13485, described in the Medical Device Compliance Program. This is  a shift from QSIT’s subsystem model to a process-focused inspection approach, a heavier emphasis on risk management, and a resultant hybrid compliance burden between a company's legacy QSR requirements and new ISO-based expectations of the QMSR.

The FDA has been working to align its QSR with the worldwide quality systems standard ISO 13485. Part of the reason for harmonizing its regulations with ISO 13485 is to reduce the regulatory burden for device makers who sell product in both…