During a July 22 Town Hall webinar, FDA officials said their new human factors guidance applies only to marketing submissions and doesn’t change MedTech manufacturers’
FDA official Josh Nipper warned medical device companies at MedCon that they remain fully accountable for the accuracy and integrity of all data submitted for
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