(a) Stand-alone software that is not distributed in packaged form (e.g., when downloaded from a Web site) is deemed to meet the UDI labeling requirements of this subpart if it complies with the requirements of paragraph (b) of this section and conveys the
CFR 21-801.50-2013 history
2013CFR 21-801.50-2013 Food and Drugs. Part801:Labeling. Section801.50:Labeling requirements for stand-alone software.