Latest Medical Device Industry News & Trends

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Comparison of current final software guidance vs new draft guidance

March 18, 2022

FDA has released a draft guidance document for industry to guide sponsors on evaluation of device software’s safety and effectiveness. “The recommendations in the new draft guidance document pertain to device software functions, including software in a medical device (SiMD) and software as a medical device (SaMD)”. The new draft guidance has in depth recommendations for every Software documentation element needed to be included in any premarket submission.