Monday, October 23, 2023

Brief Blog: FDA releases roster of over 150 new AI devices and programs

On October 19, 2023 - the day after former FDA commissioner gave a talk including several AI topics - FDA released a new "accounting" of its authorizations for AI devices.   The news was covered in detail at STAT.

The FDA added 155 new devices, representing decision dates from August 2022 to July 2023.


The FDA updated its list of AI/ML-enabled medical devices, adding 171 new products, with 155 authorized between August 2022 and July 2023. The FDA emphasized the importance of AI/ML in healthcare, noting its potential to derive valuable insights from healthcare data. The list aims to inform the public about these devices and the FDA's work in this area.

The update revealed an expected 30+% increase in 2023 (still, a slower year-on-year growth than before.) Radiology dominated the field with 87% of devices in 2022 and 79% in 2023. The FDA plans to periodically update the webpage list. 

The agency has not yet authorized devices using generative AI or large language models. FDA notes that device summaries from manufacturer do not necessarily reflect the full range and breadth of data evaluated by the FDA in its product review.  


Multiple articles in medical journals and trade journals have noted that AI should be approved and adopted with great care.   In this STAT article, they suggest the transparency follows prior concerns were raised the FDA's approach to AI device regulation.  The FDA noted that many AI device summaries lack essential details about testing demographics and locations, which hinders understanding of biases and weaknesses. The FDA's challenge will lie in in keeping pace with rapidly evolving AI technology and ensuring public understanding of these devices' inner workings.