Reading on AI and ML enabled medical devices

[sbmthakur]

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

[sbmthakur]

The list can be used as a reference for currently approved AI/ML devices.

[obscrivn]

@sbmthakur How often it is updated. Lets download data, create notebook and provide some stats for data. Perhaps you could relocate this task to Keshav or Usha who are starting on 06/15.

[sbmthakur]

FDA hasn't specified the period for updating the data. But they do mention that the list is generated from publicly available sources. One of the cited sources in that article has shared their methodology for evaluating and aggregating these devices. The methodology includes several Jupyter notebooks that we can leverage to do our analysis.

https://github.com/ericwu09/medical-ai-evaluation/

https://ericwu09.github.io/medical-ai-evaluation/#

[sbmthakur]

They are using the PMN96CUR.zip file available here. This data dump appears to be updated as the latest approved device features there too (K213760).

[sbmthakur]

The zip files are updated on the 5th of each month. Most of the FDA data (510k Clearances, Registration and Listing, Product Classification) are also updated monthly.

• https://open.fda.gov/apis/device/classification/
• https://open.fda.gov/data/product-classification/
• https://open.fda.gov/data/registrationlisting/
• https://open.fda.gov/data/510k/