07 Sep 2022 | 02:45 PM GMT
Past Meeting

Masterclass: Regulation of DTx in the US - Experience from a Real Company

About this Meeting

Are you trying to get your DTx solution regulated in the US? Would you like to learn from the experiences of a real company? Keep reading, this masterclass is for you! 

Having regulatory clearance is absolutely essential for many DTx companies to successfully bring their solution to market. Most times, knowing what is on the books is not enough to understand how you should navigate the regulatory landscape in practice. In this masterclass, we will hear about the experience from a real company; Michelle Rubin-Onur, Director of Regulatory at Blue Note Therapeutics, will walk us through the following:  

  • Regulatory pathways for SaMD in the US and how to approach the discussions with the FDA 
  • Enforcement discretion in place during the public health emergency: what should companies do when it goes away? How to plan for that? 
  • Clinical studies: how can you evaluate or consider endpoints for your solution and incorporate FDA's feedback into clinical studies?  
  • SaMD continuous improvement: what are the regulatory implications? How can companies deal with that efficiently?

About Us

HLTH Inc. is a dynamic community delivering unique value to the healthcare industry through a mix of unparalleled global events, inspirational content, and impact-driven initiatives.

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USA Event Dates

2026 | HLTH: Nov 15 – 18 | Las Vegas | Register | Sponsor
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Europe Event Dates

2027 | HLTH Europe: Jun 21 – 24 | Amsterdam | Sponsor
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