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FDA Introduces "Pre-certification" Pilot Programme for Digital Health Companies

02:00 EDT 7 Aug 2017 | The Journal of mHealth

FDA commissioner Scott Gottlieb recently announced a pre-certification pilot programme that aims to speed up the approval process for medical software companies and products that are deemed less risky than traditional medical devices. He stated that through the Pre-Cert for Software Pilot, the FDA seeks to develop "a new and pragmatic approach to digital health technology" that takes into account "the unique characteristics of digital health products and the marketplace for these tools."The

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