FDA Releases Final MDDS and Updated Mobile Medical Apps Guidance Documents

On February 9, 2015, the U.S. Food and Drug Administration (FDA) finalized its guidance, “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices” (Final MDDS Guidance), the draft version of which was released last year on June 20, 2014 (Draft MDDS Guidance) and discussed in our June 24, 2014 client update.

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