Mobile Medical Application Guidance From FDA is Coming

“[Final guidance] should be out by the end of the fiscal year” said Christy Foreman, Director of the Office of Device Evaluation, in her testimony before the House Oversight and Investigations Subcommittee on March 21, 2012. Ms. Foreman’s testi… Read More
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The FDA Regulatory Challenges of Software Interoperability and Part 806

By Casper E. Uldriks The verification of design specifications and functional validation of software is predicated on its intended use with a particular device or as a “stand alone” device. The U.S. Food and Drug Administration (FDA) and the indu… Read More
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