AI/ML-Assisted SaMD

The content of FDA's request for comments on its proposed regulatory framework for modifications to artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD) and proposed content for an algorithm change protocol are now available in StratML format at http://stratml.us/drybridge/index.htm#FDA
Here's the comment I submitted:

Consistent with the good practice set forth in section 10 of the GPRA Modernization Act (GPRAMA) and the new OPEN Government Data Act (OGDA), plans and performance reports for AI/ML-based SaMD should be published in an open, standard, machine-readable format like StratML Part 2, Performance Plans and Reports. https://www.linkedin.com/pulse/open-machine-readable-government-owen-ambur/ | http://stratml.us/references/HR4174.htm#Title_II | http://stratml.us/#Part2

Owen