FDA Predetermined Change Control Plan (PCCP) Guidance for Artificial Intelligence (AI)

[@arunasharma9432]

I am really impressed with the contents you share in youtube. Thank you for updating with focus on medical device field. Best wishes for good work.

[@MedicalDeviceAcademy]

Thank you for the positive feedback. If you have any suggestions for future videos, please add them as a comment.

[@transrepublic]

can you possibly share the original link to the FDA ESTAR Powerpoint you were using? I couldn't find it online but id love to see the entire slide presentation.

[@MedicalDeviceAcademy]

Here's a link to the eSTAR presentations we have available on KZbin: kzbin.info/aero/PLUMSoOrFSw9feiURrdenVN4et6Df5_JLX. We have 60+ more that are available as part of our 510(k) course: medicaldeviceacademy.com/510k-course/

[@38Lemma]

Enlightening thank you! Any advice for AI/ML changes for Europe ? ( without official published guidances if I am right ?)

[@MedicalDeviceAcademy]

The FDA guidance is the first of its kind that I am aware of. It is only a draft at this stage, and there is no similar draft available from the MDCG for Europe.