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Digital Health and Remote Monitoring Devices: the Impact of COVID-19 on Their Regulation

A session by Allison Komiyama
Principal Consultant, AcKnowledge Regulatory Strategies

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About this talk

This session focuses on a few case studies for how device companies were impacted by three FDA guidance documents. Allison Komiyama, PhD, RAC, Principal Consultant at AcKnowledge Regulatory Strategies will highlight pros and cons for each.

The FDA Guidance Documents to be discussed:

• Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019

• Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019

• Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the Coronavirus Disease 2019

Allison Komiyama


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