FDA proposed that all dates provided on a medical device label that are "intended to be brought to the attention of the user of the device. . .shall be presented in the following format: Month Day, Year (e.g., JAN 1, 2012)." We also proposed that labelers would have to comply with the requirements of proposed SEC 801.18 1 year after publication of a final rule. FDA received many comments (approximately 110) on the proposed date format and the proposed compliance date of the date format. Nearly all of these comments opposed the proposed date format, considered the time provided to implement this labeling change to be inadequate, or both. Although many comments recognized the benefits of standardized dates, most viewed FDA's proposal as too restrictive, too burdensome, inconsistent with the needs of international commerce, and inconsistent with existing industry practices. Comments noted that FDA's proposed date format would require different labels for a device when marketed in the United States and the same device when marketed in the European Union or other international markets. For example, comments noted that the date format required by the proposed rule "is not consistent with global requirements" and "perpetuates an opportunity for confusion" by not implementing "standardized international dating systems."
FDA agrees with these comments and has revised SEC 801.18 as discussed in this document.
One comment suggested that FDA should permit a manufacturer to use any date format it chooses, "as long as the manufacturer makes clear" what format it is using, and a similar comment suggested FDA should "should allow for multiple data formats" but should give "priority . . . to international standards." Several comments suggested that FDA should permit truncated dates, using only the year and month (YYYY-MM). This is one of the formats permitted under some international standards, such as International Organization for Standardization (ISO) 8601:2004, that were cited by comments.
FDA disagrees with all of these suggestions. Any approach that allows for multiple formats would require patients and health care professionals to spend time and effort to determine how a given labeler's dates should be interpreted. A date format that provides only the year and month could still leave users uncertain as to whether an expiration date refers to the first day of the month, or the last day of the month. This is little different from the current situation, where variation in the presentation of date confuses users and can lead to incorrect decisions, such as determining whether a device has reached an expiration date.
FDA agrees with a comment that suggested a "single specified date format will reduce confusion" concerning interpretation of dates on medical device labels, and with the many comments that suggested that FDA should abandon its proposed date format and should instead adopt a date format specified in an international standard, such as ISO 8601:2004, and consistent with international usage, including that of the European Union. If all dates were formatted in this way, "one label can be used globally for all product identification." These comments were consistent with a comment that suggested, "The manufacturing date, expiration date, and any other necessary date should be written as YYYY-MM-DD to harmonize with the ISO 8601 requirements." FDA agrees, and the final rule provides that all dates on medical device labels intended to be brought to the attention of the user must be presented as year-month-day (for example, 2013-09-30). FDA does not, however, agree with comments that suggested we should incorporate ISO 8601:2004 or any other international standard, because the standards we examined all permit multiple formats, for example, by permitting dates that use only the year and month (YYYY-MM), and truncated dates are not permitted by the final rule. In the event that a medical device expires in a particular month, but not a particular date, the labeler may choose the last day of the month for the date field.