Description: FDA has provided guidance for providing AI/ML software Predetermined and Algorithm Change Control Plans as part of SaMD regulatory submissions. The discussion will include details on the type of information to include with these AI/ML submissions and common FDA deficiency oberservations from CDRH and CBER.
Learning Objectives:
Upon completion, participants will gain an understanding or contribute to a discussion on how to present FDA with a Predetermined Change Control Plan (PCCP) per FDA expectations
Upon completion, participants will gain an understanding or contribute to a discussion on how to present FDA with a Algorithm Change Control Plan (ACP) per FDA expectations
Upon completion participants will be able to build an Artificial Intelligence/ Machine Learning device desciption suitable for EU, Health Canada and FDA
