Masterclass: Multi-Condition SaMD: Regulatory Requirements and Future Implications

Obtaining SaMD approval is no easy task, as it requires rigorous evidence generation and efficacy demonstration to ensure patient safety and usability. This becomes even more challenging when the SaMD is designed to be agnostic, meaning that it can be applied to multiple conditions. In this case, the SaMD must undergo extensive clinical evaluations, provide evidence of its performance, usability, and safety in various scenarios, and demonstrate its added value for patients and providers. This is a complex and demanding process, and can lead to the development of innovative and effective solutions that can address unmet needs and improve health outcomes across different populations and settings.

How can SaMD developers and owners navigate these complexities and unlock the opportunities of agnostic SaMD? Join this masterclass to find out!

In this session, Arrash Yassaee and Mani Shanmugham (Huma) will bring us through a case study of evidence requirements for achieving multi-condition SaMD, and the implications this brings. Specifically, we will delve into: 

• Implications of achieving multi-condition SaMD approval. What potential benefits and use cases can agnostic SaMD unlock? 

• Evidence generation strategies. What are best practices and strategies for generating robust and reliable evidence to achieve multi condition SaMD approval?

• Geographical variations in evidence requirements. How do evidence requirements and expectations for SaMD differ between the EU and US?