Obsolete: Replaced November 18, 2016
“Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices”
This MRI guidance document was issued on November 14, 1998 and it supercedes a previous guidance document issued in 1988.
Section III.3 discusses the software level of concern and identifies two different classes of magnetic resonance diagnostic devices. The first where software is used for imagery construction and processing will generally be considered to be minor level of concern. It states, however, that software whcih performs scan control functions will be considered a moderate level of concern for those systems capable of reaching the first and second level controlled operating modes as descriped in IEC 60601-2-33. This section goes on to say that for moderate level of concern in software a detailed description of the algorithms uses and a summary of the verification validation testing should be provided.
In the section of the document that addresses the IEC standard it specifically states that operation in the second level control mode requires an approved human studies protocol, and that security measures, such as a lock or software password must be provided to prevent unauthorized operation in this mode. In doing so this guidance states a functional requirement for software considered.
Section IV.C.1 defines hardware and software information to be provided including a description of specialized spectrascopic software for example, localization and post processing. Sub-section 3 which discusses system modifications mentions software changes several times and the need to identify any changes from the previous device.
Sub section 4.I is devoted to software and references the current FDA software submission guidance, “Guidance for the Content of Premarket Submission for Software Contained in Medical Devices,” and goes on to state that for software devices where software would be a minor level of concern the submission should include the software version or release number, a list and brief description of the functions perfomed by the software, a description of the software devleopment methods for example a list or diagram of steps and development and responsible departments, a list of hazards related to the software functions and the means taken to mitiagte these hazards, descriptions of the test procedures, and a certification that the software information provided in the submission is correct and that the same procedures will be used to retest and revalidate the software when it is revised.
For software that is of moderate level of concern the agency requires a detailed description of the algorithms utilized and that material previously submitted in a 510(k) that is common to more than one device need not be dupcated in subsequent submissions but can simply be referenced. So software used in multiple devices does not need to have information repeated in each submisison in which that software is used it can simply be referenced.