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14 Jul 2021 | 01:45 PM GMT
Past Meeting

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
Jessica Ash Director of Digital Health, R&DOtsuka
Jessica Ash
Director of Digital Health, R&DOtsuka
Prayat Shah Co-Founder, VP, Partnerships & AlliancesWellthy Therapeutics
Prayat Shah
Co-Founder, VP, Partnerships & AlliancesWellthy Therapeutics
Uri Goren Head of InnovationMeir Medical Center
Uri Goren
Head of InnovationMeir Medical Center
Zina Manji Founder/Principal, Regulatory StrategistInnopathwayz, LLC
Zina Manji
Founder/Principal, Regulatory StrategistInnopathwayz, LLC

About this Meeting

Regulation is an absolute essential for  DTx companies who want to be accepted into clinical and payer groups. What are the must know and do’s and don’ts when attempting to take your DTx product through regulatory pathways in the US? Join us in this Masterclass led by AmalgamRx to learn more about: 

  •  The evolution of the US regulatory regimes for SaMD: FDA Pre-Cert program What should DTx companies go after as a SaMD maker - de novo, breakthrough device or classic 510k?  
  •  FDA Digital Health Center of Excellence (DHCoE): focus and roadmap 
  •  Changes expected in the US regulatory regimes for SaMD in the next 2 years

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