Abstract
On February 2, 2026, the FDA's Quality Management System Regulation (QMSR) took effect, replacing 21 CFR Part 820 and incorporating ISO 13485:2016 by reference. One day later, FDA reissued its premarket cybersecurity guidance to align with it. FDA classifies the guidance itself as Level 2 — a technical alignment rather than a substantive policy change — but the inspection context is new: under Compliance Program 7382.850, which replaces the legacy QSIT model, security findings now surface within design controls, CAPA, and risk management reviews as routine inspection items.
For cyber device manufacturers, cybersecurity is no longer a standalone compliance exercise — it is now an integral part of the quality management system. Incomplete cybersecurity content can trigger FDA's Refuse-to-Accept authority at submission and generate inspection findings against the QMS itself.
In this webinar, two industry experts will break down what these regulatory changes mean in practice — and what you need to do now to stay compliant.
Which products fall within FDA's "cyber device" definition under §524B(c) — including edge cases that catch manufacturers off guard (dormant wireless, service-only interfaces, future-connectivity-capable designs)
