Posted in Regulatory and Compliance by MDDI staff on November 21, 2016
The FDA has released a final guidance on Medical Device Reporting for Manufacturers. This follows the corresponding draft guidance of July 2013 and replaces the guidance of March 1977, which is no longer available on FDA’s website. That guidance was ambiguous with regard to the reporting of non-injurious malfunctions caused by user error. Among various revisions from the 2013 draft is the treatment of user error, which the guidance also calls “use error.”
To many, these terms are not interchangeable since user error seems to denote clear fault (the user) while use error identifies what happened but leaves the cause open. For instance, the error might have been caused or facilitated by inadequate labeling or bad design. The term “use error” was introduced in MD+DI in 1995 and has since been widely adopted.
FDA notes with regard to use errors that “such errors often reflect problems with device labeling, the user interface, or other aspects of device design.” Further, FDA states that it “believes that these events should be reported in the same way as other adverse events which are caused or contributed to by the device.” It then goes on to say that such errors related to deaths and serious injuries are to be reported, as has been the case. However, use errors associated with malfunctions that did not result in death or serious injury no longer have to be reported, according to the new guidance.
This is a change from the draft and may reflect feedback from industry participants who did not want to have to report use errors that weren’t associated with deaths or serious injuries. It may also be that FDA decided they didn’t want to deal with such reports. Unlike the preamble to rules and regulations, which are sometimes cited as agency policy and give a—more or less—detailed analysis of why an agency made the decisions it did, guidance documents are issued without such analysis being publicly reported.
So much for transparency. In contrast, the 1995 MDR Final Rule included 20 pages of notes and comments in the three-column Federal Register format.