Dealing with Artificial Intelligence in the Context of the further Development of Software in Medical Devices

The topic of artificial intelligence/machine learning (AI/ML) is currently all around. The FDA has also taken up this topic and published various draft guidance documents.  A current draft is aimed at manufacturers of medical devices that contain software. What does it say?

AI/ML is already used in medical devices, so the FDA wanted to take up the topic in a regulatory way with an eye to the future. The advantages of AI/ML are obvious. It offers the potential to transform healthcare. Big existing data offers opportunities in deeper insights. Improvements in medical devices could be generated by AI/ML, up to earlier detection of diseases and further development of personalised medicine.

The application of AI/ML to medical device software and its further development is an iterative process that the FDA would like to accompany with the draft guidance "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions". The aim of the document is to provide guidance for the modification of this software. At the same time, however, the safety and effectiveness of the medical device should be maintained. The guideline then mentions a "Predetermined Change Control Plan" (PCCP) as the means of choice for such a development, which is submitted as part of the approval. It should contain:

• The changes planned  
• The methodology to be used and developed 
• Issues related to the implementation of these changes 
• The validation of the changes

This PCCP will then also be evaluated by the authority as part of the authorisation activities. Further details, including example elements of a PCCP (Appendix A) and possible product use examples for a PCCP (Appendix B), can be found in the draft guidance "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions" itself.