Wednesday Wisdom: Article on Regulating Software as a Medical Device (SaMD)

In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of current and former FDA reviewers, scientists, engineers and regulatory and quality experts, and adds additional expertise with FDA submissions. The author of this post is a member of this team, which has done significant work with novel and/or high-risk devices focusing on pre-submissions, 510(k)s, IDEs, PMAs, De Novos, Breakthrough Designation Requests and Safer Technology Program Requests. 

Check out a recent article written by our team on the Regulatory Affairs Professionals Society (RAPS) website HERE. In the article she discusses the rise of software as a medical device (SaMD) and how the regulatory landscape is changing for these devices. Read the abstract below, and in case you missed it, HERE is the link again to read the full article!

Regulating Software as a Medical Device in the age of Artificial Intelligence

Posted 30 May 2019 | By Michelle Rubin-Onur, PhD

“This article summarizes the current and proposed regulatory landscape for software as a medical device (SaMD) with artificial intelligence and machine learning capabilities. The author provides definitions for SaMD, categorization and testing features and how to approach and adjust regulatory pathways for SaMDs that “learn” by using real-world evidence to continuously adapt and improve and, therefore, may need to be re-submitted for a new premarket approval due to changes to the device via its adaptations. Because the regulatory system does not currently take into consideration SaMDs using Artificial Intelligence (AI) and Machine Learning (ML) to continually adapt, FDA has initiated a conversation with SaMD stakeholders to develop an appropriate regulatory pathway to accommodate AI/ML SaMD continuous adaptation.”

You can find a link to the full article here!