Part 5: FDA Remote Ophthalmic Assessment Guidance | COVID-19


Remote Ophthalmic Assessment Guidance

Navigating the Regulatory Pathway during a Global Pandemic

What are the motivations for the COVID-19 ECMO Bypass Devices guidance?

    • Remote connectivity and analysis would facilitate telemedicine treatment of patients.
    • Modified Ophthalmic devices may be able transmit patient parameters to providers remotely.
    • Some devices may be able to analyze parameters and alert providers to disease state/severity.

What medical device types are covered by this guidance?

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