Recently, the FDA released a guidance document regarding Artificial Intelligence algorithms for comment. What is your thought on AI processes under FDA regulation? https://www.fda.gov/medical-devices/software-medical-device-samd/global-approach-software-medical-device-software-medical-device
top of page
bottom of page
I think the guidelines are reasonable and a good start. The intended use risk profile is particularly helpful for developing machine learning algorithms. We also get a new acronym GMLP , Good Machine Learning Practice. Looking forward to having our pre-submission meeting with FDA for the SaMD we are developing.