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Michael, That link was a good resource of first-year experiences with diversity plans. It looks like, at least for Oncology related applications, most of the feedback was on enrollment goals, enrollment monitoring, and enhancing strategies to meet goals. I assume that observation infers we need to have ...

Himang, Based on your description that the general system is readily available and used in other medical devices, the device wouldn't be considered new or novel. In my opinion, the "new" or "novel" component warrants additional supporting details but doesn't substantively change obligations for a thorough ...

Stephanie, I know you didn't receive a reply on the thread and request for enrichment study designs, but would you be willing to share what else you learned or the approach you took? Cheers, Andy Hadd ------------------------------ Andrew Hadd Director of Regulatory Affairs Natera Austin TX United ...

Hello. I am interested in collating examples where FDA clearly delineates between training and validation data. One example comes from Good Machine Learning Practice for Medical Device Development: Guiding Principles | FDA: "Training and test datasets are selected and maintained to be appropriately ...

Nancy, Thank you for the follow up and work you are doing in this area.  Please see below for a collection of questions that may be applicable to fostering "good thinking" skills for regulatory professionals.  I hope the questions provide clarity on the goals for those sessions and might be useful as ...