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 roundtable to find out! In this session, we will go 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 to develop studies and evidence requirements that meet the needs of all international markets

We would like to remind you that our meetings are small and intimate sessions with a limited number of seats available, therefore we rely on your attendance and participation to ensure a high quality and valuable meeting for all. If you are confirmed for this meeting we ask if you can please ensure your attendance on the day.