The Software as a Medical Device [saMD] Regulatory Landscape in The Us and Europe

The advent of artificial intelligence (AI) in the healthcare industry has resulted in a proliferation of novel health technologies with intuitive features. However, the regulatory landscape for such innovative products has yet to be fully understood. The US Food and Drug Administration (FDA) published a discussion paper on AI- and machine learning (ML)‒based software as a medical device (SaMD) in April 2019, which led to the release of an action plan that incorporated stakeholder feedback on the original discussion paper. The present article sheds light on the regulatory landscape for SaMD in the US and Europe and examines the future direction for SaMD.

Genpro’s Medical Writing and RWE team has written this interesting article on Regulatory Affairs Professionals Society (RAPS)’s official publication Regulatory FocusTM to shed light on the regulatory landscape for software as a Medical Device. Dr. Kapil Khambholja, Head of Medical Writing, and Mr. Vatsal Chhaya, senior Medical Writer at Genpro Research explain how AI and machine learning will become an integral part of our lives, just as medicines and medical devices already are.

They wrote “Given the country-specific differences in regulatory mechanisms for approving AI-based SaMDs and getting them to market, the challenges for harmonization of regulatory standards and their implementation are substantial,”. “Nevertheless, future applications of AI-based SaMD, with its total diffusion in health systems of individual countries and supported by health technology assessment‒like neutral mechanisms, could be a reality in the near future.” RAPS also highlighted the same in their communication.

The full publication can be read at

Reach out to Genpro’s team for strategic consulting needs for your MedTech initiatives for software-based or other categories of medical devices. We can work with you on regulatory documentation, CER & literature reviews, clinical trial or other data analytics, HTA, and many more needs in this domain.