VP, Digital Health, AI, and Radiology MCRA, and IQVIA company Washington, District of Columbia
Alex will describe the latest thinking of FDA for topics such as clinical decision support, good machine learning practice, and other digital health considerations to help the audience better understand FDA's regulation and expectations in this space. Clinical decision support is a controversial topic in medical devices and the exemption from the definition of a medical device describe in the law and FDA's guidance is much narrower than many in industry realize. Good machine learning practice as defined by FDA are necessary to ensure that AI medical devices have been trained, validated, and documented based on practices. Knowledge of this practice should be built into the software and AI development process to ensure success with FDA submissions. Other digital health topics and FDA policy will be discussed as they evolve with the new administration.
Learning Objectives:
Upon completeion, participant will be able to understand FDA's perspective on topics such as clinical decision support, good machine learning practices, and other digital health policies and how they affect device and study design.
The participant will also understand the history and statutory basis of to these regualtory topics.
The particpant will also understand the FDA's latest thinking and policy on these regualtory topics as available from the new administration.
