Day

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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"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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Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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