FDA issued an analysis of Premarket Review Times under the 510(k) Program. In two samples of submissions it analyzed software deficiencies in the submissions were noted in 14-20% of the submissions analyzed. The deficiencies included no software documenation provided, missing software description, missing trace matrix, missing list of anomalies, and/or missing validation. In addition form 3654 required to document use of standards was omitted in 24-30% but this was not restricted to software.