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26 Jul 2022 | 02:45 PM GMT

Masterclass: The Regulation of DTx in the US

Anchored by:

Jason Brooke
Attorney & Managing Member
BROOKE CONSULTING

Participants:

Jason Brooke Attorney & Managing MemberBrooke Consulting
Jason Brooke
Attorney & Managing MemberBrooke Consulting
Adriano Garcez Director, DTx/SaMD Evidence GenerationZS Associates
Adriano Garcez
Director, DTx/SaMD Evidence GenerationZS Associates
BB
Brian Binkowski Director of QualityTwill
BB
Brian Binkowski
Director of QualityTwill
Brian Binkowski Director of QualityTwill
Brian Binkowski
Director of QualityTwill
Chris Cera CEOArcweb Technologies
Chris Cera
CEOArcweb Technologies
Emma Carr Co-Founder and Chief Scientific OfficerAmara Therapeutics
Emma Carr
Co-Founder and Chief Scientific OfficerAmara Therapeutics
Jo Masterson CEO and Co-Founder2Morrow, Inc
Jo Masterson
CEO and Co-Founder2Morrow, Inc
Susanne Gruber Strategic Healthcare AdvisorIgnited Vision
Susanne Gruber
Strategic Healthcare AdvisorIgnited Vision
Wen Dombrowski MD MBA Chief Convergence OfficerCATALAIZE
Wen Dombrowski MD MBA
Chief Convergence OfficerCATALAIZE
Zina Manji Founder/Principal, Regulatory StrategistInnopathwayz, LLC
Zina Manji
Founder/Principal, Regulatory StrategistInnopathwayz, LLC

About this Meeting

How to successfully take a DTx product through the regulatory pathways in the US? What is going to happen to SaMD products that were marketed under the enforcement discretion during Covid? In DTx-pharma partnerships, what is pharma responsible for from a regulatory perspective? 

HealthXL members often ask these questions in our meetings, seeking advice and best practices in their regulatory strategies in the US. However, knowing the answers can be difficult. Join this US-focused Masterclass led by Jason Brooke, medical device attorney and regulatory/quality advisor. He will walk us through:  

  • Current status of SaMD regulation: what does the regulation of SaMD look like? What should digital health companies go after as a SaMD maker - de novo, breakthrough device or classic 510k?   
  • Regulation differences between clinical decision support software and SaMD 
  • What will the regulation of DTx look like in the next few years? What pilots are under testing, evaluation or discussion (e.g. FDA Pre-Cert Program, proposed regulatory framework for AI/ML-based SaMD, etc)?  
  • Recommended approach for developing the best regulatory strategy for a DTx product