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US FDA: Calling All Digital Health Gurus

FDA wants to draw on outside expertise to help it better understand the digital-health industry and to develop its proposed Digital Health Software Precertification Program. The agency is seeking applicants for its Entrepreneur-in-Residence program in the coming months expressly for this purpose.

When US FDA's device center is faced with a particularly sensitive and difficult regulatory issue, it tends to ask outside experts to help figure out how to deal with it. In that spirit, the agency is asking experts with industry experience to spend six months working for it on a part-time basis to help develop a new pathway to speed digital-health products to market.

On Sept. 6, the agency announced an Entrepreneur-in-Residence program to help it develop the newly announced Digital Health Software Precertification Program. The Pre-Cert Program which is currently being...

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