Search Results for precertification pilot

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Help Wanted: FDA Seeks Digital Health Entrepreneurs By Zachary Brennan - Published 06 September 2017

Details of how the US Food and Drug Administration (FDA) is planning to tackle the growing digital health industry are slowly trickling out and on Wednesday the agency announced it will establish an Entrepreneur-in-Residence (EIR) Program to support and help develop its Software Precertification (PreCert) Pilot Program.

Categories: News, US, FDA, Government affairs, Medical Devices

Tags: digital health and FDA, precertification pilot

FDA Offers More Details on Digital Health Precertification Pilot By Zachary Brennan - Published 09 August 2017

The US Food and Drug Administration (FDA) this week sought to answer some frequently asked questions regarding the roll out of its new precertification pilot program for digital health products, which is expected to begin 1 September and only include nine participants.

Categories: News, US, FDA, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: digital health, precertification pilot for digital health, FDA digital health