Erkang Ai, Ph.D.

Erkang Ai, Ph.D.

Hogan Lovells

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FDA’s Software Pre-Cert Program: More Details Revealed

In follow up to the U.S. Food and Drug Administration’s (FDA) late July announcement of the Digital Health Innovation Action Plan and the pilot Software Precertification (Pre-Cert) program, the Agency held an August 1, 2017,...more

8/10/2017  /  21st Century Cures Initiative , Digital Health , FDA Approval , Food and Drug Administration (FDA) , International Medical Device Regulators Forum (IMDRF) , Medical Devices , Medical Software , Regulatory Standards
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