FDA released a premarket submission guidance titled: “Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers” with an issue date of 9-Sept-2008. This guidance mentions software/firmware in several section and sets the default Level of Concern for software in ultrasound systems as moderate while in the past it has usually been minor. It also indicates that if the risk of certain portions of software is lower it may be acceptable to include less documentation for those portions.
The guidance states specific software information in a number of sections including requiring:
– documentation of in the acoustic output measurement of your transducers including …software,…
– Sec. 1.6.1.4 “…describe your procedures for assuring that when either hardware or software changes are made, the effects of these changes on the acoustic output are assessed, and, if necessary, are then measured, documented, and incorporated into the labeling and, if applicable, output display”
– Sec. 1.7.5 “…your 510(k) submission also provide a summary description of new or altered algorithms and an explanation of why they are suitable for the chosen task.”