Despite FDA staffing changes, the agency’s medical device review performance remains strong, according to former FDA leader and current QHub Corporate VP Sean Boyd, who
As makers of medical devices expand their use of AI to generate SOPs and other controlled documents, the focus is shifting from content creation to
At MedCon 2026, FDA official Barb Marsden acknowledged growing strain on medical device review timelines driven by staffing shortages and MDUFA-related workload pressures, while stakeholders
The FDA is integrating generative AI into its product review process to streamline repetitive tasks, improve consistency, and accelerate innovation. An expert urges MedTech and
The FDA’s rollout of generative AI aims to streamline drug and device reviews, but experts warn of risks like algorithmic bias and “AI poisoning” that