FDA CDRH’s 21 CFR Part 806 Medical Device Corrections and Removals defines requirements for reporting and record keeping related to device corrections and removals (which include software corrections and removals). The preamble specifically mentions software in one case. The excerpt follows and the full rule is attached:
“17. One comment states that a “bug list” distributed by device
manufacturers to customers advising them of problems associated with
software equipment used to run work stations could be considered a
correction to software.
A manufacturer, importer, or distributor that undertakes a
corrective or removal action for computer software that is considered a
medical device must submit a report of such action to FDA. If the
action is taken to reduce a risk to health or to remedy a violation of
the act that could present a risk to health caused by computerized
software that comes within the definition of a device, a report must be
submitted; however, it is not likely that a “bug list” would be
considered a removal. A “bug list” could be considered a correction
if it constitutes relabeling, but again, would only be reportable if it
was undertaken to reduce a risk to health or to remedy a violation of
the act that could present a risk to health.”
SoftwareCPR keywords: recall, fix.