US FDA Reissues Cybersecurity Guidance to Reflect QMSR Transition and ISO 13485 Alignment

The FDA reissued its medical device cybersecurity guidance on 4 February to reflect the transition from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) and the formal incorporation of ISO 13485; the revision updates regulatory references, aligns design, risk management and inspection expectations with ISO clauses, removes certain prior QSR design control citations, and changes inspection programs and techniques. No security incident, exploit, or compromise is reported.