Day

August 3, 2017
03
Aug

FDA Digital Health Precert Transcript and Video

August 3, 2017
The FDA held a meeting and webcast regarding initial development of its new approach for Digital Health Regulation. The FDA’s Digital Health Precertification webpage is at the link provided, and the slides from their presentation can be downloaded.
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03
Aug

FDA Digital Health Precert Meeting Summary

August 3, 2017
"Based upon the company’s precertification level and the level of risk for the device, the product (or modifications to a product) may be able to go directly to market or undergo a streamlined submission review"
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IEC 81001-5-1 Cybersecurity Lifecycle

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IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

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