ARTICLE SUMMARY:
In this week’s Pathways Picks: CDRH taps new Office of Product Evaluation and Quality director, and rolls out key guidance on electronic submissions, adverse event reporting, and AI devices; Australia’s Therapeutic Goods Administration is seeking input on regulatory policies and guidance and is cracking down on spine stimulation device safety; UK NICE addresses AI from different vantage points; and dates to remember.
FDA Picks
A new hire and a busy guidance week:
CDRH hires industry and army veteran in key post. FDA’s device center plans to bring on former device industry executive and surgeon Ross “Rusty” Segan, MD, as its new director of the important Office of Product Evaluation and Quality (OPEQ). Segan, who doesn’t have any specific regulatory affairs experience, works as a consultant for device companies and he previously served as chief medical officer of Olympus and other medtech firms. He’s also a trained surgeon who performed minimally invasive surgeries for the US Army, including a deployment in Afghanistan, where he suffered a spinal injury that ended his clinical career. For more in Market Pathways, see “CDRH Taps Former Industry Exec, Surgeon to Run Evaluation and Quality Office.”
