USAEUROPEViVE
ABOUTSPONSORSHIPFOUNDATION
Logo Hlth
Logo Hlth
07 Dec 2021 | 03:45 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
Adam Samson Adjunct FacultyGeorge Washington University
Adam Samson
Adjunct FacultyGeorge Washington University
Hannes Klöpper FounderHelloBetter
Hannes Klöpper
FounderHelloBetter
Jared Augenstein Senior Managing DirectorManatt Health
Jared Augenstein
Senior Managing DirectorManatt Health
Jim Howard CEOReadout Health
Jim Howard
CEOReadout Health
Mariam Shokralla Digital Health StrategistHIMSS
Mariam Shokralla
Digital Health StrategistHIMSS
Peter Hunter Johnston ConsultantblueBriX
Peter Hunter Johnston
ConsultantblueBriX
Pramod Prabhakaran Faculty and HealthTech AdvisorNational Association of Primary Care (NAPC)
Pramod Prabhakaran
Faculty and HealthTech AdvisorNational Association of Primary Care (NAPC)
Rafal Zasadny Sr. RA managerBayer Consumer Care AG
Rafal Zasadny
Sr. RA managerBayer Consumer Care AG
Ricardo Sainz Fuertes Global Director Digital Health SolutionsEISAI
Ricardo Sainz Fuertes
Global Director Digital Health SolutionsEISAI
Rick Bartels President/Founder DTxCC
Rick Bartels
President/Founder DTxCC
Vasyl Pyrozhyk Vice PresidentSMBC
Vasyl Pyrozhyk
Vice PresidentSMBC

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: 

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