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FDA’s Approach for Digital Health & Policies During COVID-19
Monday May 25, 2020 16:30-18:00
COVID-19 caught us all by surprise and really shuffled the cards in all aspects.
For some companies this era was an opportunity to increase sales and customer engagements and for other to reinvent themselves and better structure their product and go to market strategy – Regulation Strategy is one of them!
Use the time to reinforce your company with the regulatory framework needed for market penetration and expansion.
FDA’s Regulatory Approach for Digital Health
• Decision Tree for Determining When Products Are FDA Regulated
• Regulatory Framework for Medical Devices
o Regulatory Pathways (510(k), De Novo, PMA)
o General and Special Controls
• Unique Regulatory Issues for Digital Health, Including:
o FDA’s Evolving Framework for Reviewing and Managing Changes to AI-based software
o Cybersecurity Considerations
Update On FDA Policies During The COVID-19 Pandemic
• Day to Day Experience Working with the Agency
• Update On Review Times and Processes with the Agency
• FDA’s Emergency Use Authorization Process
• New Enforcement Discretion Policies for Digital Health
Yarmela Pavlovic, Partner at Manatt, Phelps & Phillips, LLP
Free of charge registration
For Registration Click Here