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Software as Medical Devices (SaMD) Growing Regulatory Trends and Opportunities for Innovators

With SaMD attracting larger players and devices like the Apple Watch, FDA and regulators globally, are developing frameworks for regulating these more efficiently. On Sept 11th, 2018 Apple obtained FDA...
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FDA gives thumbs up to digital submissions

In a proposed rule announced 13 September, US FDA plans to do away with paper submissions. The agency isn’t quite going fully digital yet – you still have to mail...

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