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The pdf at the link provided is a list of detectable flaws which a manufacturer could be expected to identify and remove. This was provided to the 62304 working group by the FDA for consideration during the work on the second edition of 62304. Although there has been no study made, the FDA estimates that up to 50% of the software recalls are caused by items on this list. These flaws may once have been grouped together as ‘memory corruption’ or as ‘run-time failures’ which was not helpful in avoiding or debugging them. Use of static analysis to search for and find these flaws can eliminate a very large proportion of these run-time errors at low cost during development. SoftwareCPR advice is that since this was provided by FDA staff it might be worthwhile especially for higher risk devices, to be prepared to explain how you have used static analyzers or other methods to detect or prevent these types of errors. This document was assembled for subscribers to our Standards Navigator service but is being made more widely available as an example of the value of this service and as a professional courtesy.