Cyber Resilience Act deadline 2027 looming over unprepared manufacturers
In-depth analysis of the EU Cyber Resilience Act deadline in 2027, its 2026 reporting duties, and what manufacturers must implement now to keep products on the EU market.
Category: Med-Device Compliance
FDA Mental Health Chatbot Rules Tighten Amid Rising AI Risks and Hype
The FDA’s announcement, published in the Federal Register, highlights the “novel risks” posed by devices having Mental Health Chatbots and signals a shift toward more stringent oversight to ensure safety and efficacy. This article explores the implications of these regulatory developments, the evolving landscape, and what it means for companies and users alike.