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When Software is a Medical Device: The FDA Guidance on Premarket Submissions for Device Software Functions

When Software is a Medical Device: The FDA Guidance on Premarket Submissions for Device Software Functions

by Ismail Amin | Mar 28, 2022 | Healthcare, News

Are smartwatches and smartphones now considered “Medical Devices” under the Food Drug & Cosmetic Act? Questions like these have began percolating throughout the world as consumer based devices become more sophisticated and provide medical information to consumers...
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