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19 May 2022 | 02:45 PM GMT
Past Meeting

Masterclass: The regulation of SaMD 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
Amir Zur Head of R&D Digital Health ProductsTakeda
Amir Zur
Head of R&D Digital Health ProductsTakeda
Chris Cera CEOArcweb Technologies
Chris Cera
CEOArcweb Technologies
Jin Lee Director of Digital HealthAstellas Pharma, Inc
Jin Lee
Director of Digital HealthAstellas Pharma, Inc
Maxime Champain Search & Evaluation lead, External InnovationBiogen
Maxime Champain
Search & Evaluation lead, External InnovationBiogen
Omri Shor CEOMedisafe
Omri Shor
CEOMedisafe
Paul Wicks Founder & Chief Evidence OfficerProofStack Health
Paul Wicks
Founder & Chief Evidence OfficerProofStack Health
Rick Bartels President/Founder DTxCC
Rick Bartels
President/Founder DTxCC
Sarah Hersey Vice President, Precision MedicineBristol Myers Squibb
Sarah Hersey
Vice President, Precision MedicineBristol Myers Squibb
Shwen Gwee Member of the Advisory BoardNew Enterprise Ventures
Shwen Gwee
Member of the Advisory BoardNew Enterprise Ventures

About this Meeting

Regulation is an absolute essential for companies who want to get their SaMD accepted into clinical and payer groups. What are the do’s and don’ts when attempting to take your SaMD through regulatory pathways in the US? 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? Why is it so challenging to regulate and how is the FDA responding today? 
  • Understanding the existing regulatory pathways: what should digital health companies go after as a SaMD maker - de novo, breakthrough device or classic 510k?  
  • Regulatory Innovation at the FDA and its impact on SaMD: 
    - What will the regulation of SaMD look like in the next few years? 
    - What pilots are under testing, evaluation or discussion (e.g. FDA Pre-Cert Program, framework for GMLP, software change management etc)? 
  • Recommended approach to use today for developing, launching and evolving SaMD under current regulatory frameworks and guidance.

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