FDA Full Field Digital Mammography Guidance

FDA published a new guidance: ” Class II Special Controls Guidance Document: Full-Field Digital Mammography System”. The full document is at the link provided. This guidance mentions software in several places and also lists specific risks to health to address. It references the general FDA software submission guidances and states that the software in these systems should be considered MODERATE Level of Concern for the purpose of submission documentation. Since such systems are used in cancer screening it is interesting that FDA chose Moderate. This guidance supercedes the prior 2001 guidance.