AI & CDS Regulatory History and Current FDA Tools

Date: May 2024

Speakers:

• Alex Friedman, PhD RAC – Staff Regulatory Affairs Specialist at Beckman Coulter

He has a Ph.D. in Bioengineering from the University of Pennsylvania, USA, and is a member of RAPS with RAC certification. Alex has worked in regulatory affairs for medical devices for over ten years and has direct experience with FDA and Notified Body interactions concerning classification of medical devices. He has generated electromechanical and software regulatory strategies and submissions for the US, EU, Canada and China. He has served an R&D specialist, research associate and business consultant for business, academia and non-profit organizations. Past research experience is in muscle mechanics, motor proteins and fluorescence microscopy. Current regulatory activities are for Clinical Decision Support software applications.

Alexander Freidman is a Staff Regulatory Affairs Specialist with Beckman Coulter. He has a Ph.D. in Bioengineering from the University of Pennsylvania, USA, and is a member of RAPS with RAC certification. Alex has worked in regulatory affairs for medical devices for over ten years and has direct experience with FDA and Notified Body interactions concerning classification of medical devices. He has generated electromechanical and software regulatory strategies and submissions for the US, EU, Canada and China. He has served an R&D specialist, research associate and business consultant for business, academia and non-profit organizations. Past research experience is in muscle mechanics, motor proteins and fluorescence microscopy. Current regulatory activities are for Clinical Decision Support software applications.

• Priyanka Sathe, MSc MS – Staff Regulatory Affairs, R&D – Quality Beckman Coulter

Priyanka Sathe has over 15+ years of experience in the medical device industry. She has a strong regulatory affairs background with expertise in building complex strategies, putting together appropriate device classification and executing submissions with FDA and other notified bodies. She has worked on disposable devices such as needles, syringes, catheters as well as IVD instruments, assays and complex software products (MDDS, CDS, SaMD etc.) Priyanka has experience in FDA (US) as well as international (EU/IVDR/MDR/Canada/China/Japan/APAC/SEA) regulatory strategy and submissions.

• There are currently more than 850 FDA-authorizations enabled by artificial intelligence (AI) and machine learning (ML). While these products are intended to have positive impacts on patients and health systems, the recent cultural noise surrounding AI has caused controversy and unease.

• Alex Friedman, PhD, RAC, and Priyanka Sathe, MSc, MS will cover the latest guidance from the FDA on the use of AI-enabled products in healthcare, including:

o The history of clinical decision support (CDS) regulation by the FDA

o The FDA Digital Health Center of Excellence

o The latest online resources to evaluate AI-software applications

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