FDA Releases Working Model for Digital Health Software Precertification Program, Calls for Stakeholder Input

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FDA Releases Working Model for Digital Health Software Precertification Program, Calls for Stakeholder Input

Pilot Program May Establish Principles Eventually Applied to Regulation of Other Types of Devices

Dennis Tosh

May 1, 2018 at 11:28 AM EST

The FDA April 26 released a working model for its Digital Health Software Precertification (Pre-Cert) Pilot Program, a voluntary initiative through which medical product software developers could demonstrate an “embedded culture” of quality and company excellence, and thereby enable some products to come to market without premarket review or with a streamlined premarket review... Read More

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FDA Releases Working Model for Digital Health Software Precertification Program, Calls for Stakeholder Input

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FDA Releases Working Model for Digital Health Software Precertification Program, Calls for Stakeholder Input

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