Digital Health: QA, RA & CA Forum

FDA Webinar - Clinical Decision Support Software: Draft Guidance (2019)

• Presentation

here is the list of FDA guidance's for digital health (SaMD & SiMD)

https://www.fda.gov/medical-devices/digital-health-center-excellence/guidances-digital-health-content

Looking for a list of FDA approved AI/ML devices?

Down the bottom you will find all approved devices are listed in reverse chronological order by Date of Final Decision.

The database page will include a link to the FDA's publicly available information.

https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices