Regulatory Challenges of Medical Device Software: The world of SaMD’s and beyond!

January 15, 2026. 1PM ET

The phrase Software as a Medical Device (SaMD) is defined by the International Medical Device Regulators Forum (IMDRF) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”  Seems simple enough… but if it is, why do so many companies get it wrong?

More importantly, using the phrase Software as a Medical Device takes a particularly myopic view of the medical device software universe.  Why? Because there are multiple categories of software regulated by FDA including software as a medical device (SaMD), software in a medical device (SiMD), mobile medical applications (MMA), software used in the manufacture or maintenance of a medical device, software in combination products… the list is virtually endless!

To make things even more complicated: there is medical device software that is sometimes regulated by FDA and sometimes not (i.e., clinical decision support software (CDSS)).  There is software that is NOT regulated by FDA at all (i.e., wellness devices).  There are multiple function device products (MFDP’s) that may contain several functions, some of which are subject to FDA’s regulatory oversight as medical devices, while others are not – all within the same “device”.

Finally, some software utilizes artificial intelligence and/or machine learning (AI/ML) either pre-market or post-market or both!  In fact, as of May, 2025, there were >1250 regulated devices that were cleared or approved by FDA claiming to use AI/ML.

This webinar will take a broad approach to the topic of medical device software including:

• What is medical device software and when is it regulated by FDA?
• What are the types of software regulated by FDA?
• What are examples of medical device software from various categories?
• What are the “unique” challenges of machine learning and/or artificial intelligence (ML/AI)?
• How to plan for future change (i.e., L2F/s510k/PMA supplement vs. Predetermined Change Control Plans (PCCP))
• What are the challenges of software in combination products, i.e., digital pills, digital inhalers and beyond?
• How is medical device software regulated internationally, i.e., outside the US?
• What’s “new and exciting” in medical device software and what does the future hold?

This webinar will expose participants to a broad range of categories of medical device software (not just SaMD’s!) and the regulatory challenges they pose both now and in the future.  Participants will learn best practices to avoid timely and costly mistakes and creative ways to use regulatory requirements to their advantage!