FDA has released a draft guidance document for industry to guide sponsors on evaluation of device software’s safety and effectiveness. “The recommendations in the new draft guidance document pertain to device software functions, including software in a medical device (SiMD) and software as a medical device (SaMD)”. The new draft guidance has in depth recommendations for every Software documentation element needed to be included in any premarket submission.
This brief review will give high level differentiation between the existing vs new draft SW guidance and throw some light on “SW documentation level” evaluation. The following Table 1 summarizes the high-level differences between the two guidance documents.
Table 1: Current guidance vs new draft guidance:
Current final guidance (2005) | New draft guidance (2021) | |
SaMD vs SiMD | Focuses on SiMD. Not direct recommendations for SaMD | Focuses on SiMD, also provides direct recommendations pertaining to SaMD |
Recommended consensus standards |
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Applicability to premarket submission |
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Documentation required for any premarket submission | Determined by level of concern
| As per “four risk-based factors” and falls under:
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Examples on documentation level evaluation | No | Yes |
The subsequent sections explain how the SW documentation level evaluation were done so far (using current guidance) and how it will be done in near future once the new draft guidance being finalized.
According to the current guidance “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, may 2005”, the software documentation required for premarket submission is being determined based on the software level of concern (it can be evaluated by answering key questions provided in the current guidance document under Table 1 & Table 2). These levels of concerns were constructed by FDA in the context of giving an idea to the sponsor on software documentation required for premarket review and “is not related to device classification (Class I, II or III) or to hazard or risk analysis per se”.
When a software falls under the ‘minor’ level of concern, sponsors need to provide basic software related documentation (refer table 2 below). Moreover, if a software is determined to be either ‘moderate’ or ‘major’ level of concern, sponsor should provide all software development related documents (refer table 2 for the list). For complete list of documents refer the guidance document.
As per the new draft guidance “Content of Premarket Submissions for Device Software Functions, Nov, 2021” recommendation, the software documentation level (either ‘Basic’ or ‘Enhanced’) required for premarket submission will be determined based on the “four risk-based factors”. The concept is simple, if the answer to any one of the four risk-based questions is yes, then the sponsor should submit documents to FDA as per ‘Enhanced documentation level’.
Table 2 below brief’s the list of software related documents required to be included in any premarket submission when a SaMD/SiMD falls under the ‘basic documentation level’. As per the new “four risk-based factors” if the SaMD/SiMD falls under the ‘Enhanced documentation level’, the sponsors are recommended to provide all the basic level documents plus complete SDS document and complete V&V testing (Protocol & results) for unit, integration, system level.
Table 1: Outline of Recommended documentation as per current and new draft guidance’s:
Current final guidance (2005) | New draft guidance (2021) | ||
Minor | Moderate or Major | Basic | Enhanced |
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This easily accessible guidance document describes information’s needed during software development, V&V activities. The well described examples on documentation level, architecture diagram charts and detailed recommendations for every software element will be handy for engineers’/sponsors while developing a SaMD/SiMD. Additionally, the new draft guidance document indicates that the Agency is planning to update the “Off-The-Shelf” (OTS) Software guidance in near future (after finalizing this draft guidance) to be consistent with this new draft guidance (i.e, to remove ‘level of concern’ factors from OTS guidance too). Sponsors/regulatory folks, watch out for revised OTS guidance soon!
Of course, it is a draft guidance and open for public comments, but this draft guidance is much improved compared to the previous version (2005). Once it gets finalized, the transition is going to be burdensome for the regulatory professionals handling large SaMD/SiMD submissions (specifically for the Software’s fall under minor level concern now), since the ‘Basic Documentation level’ requirement is robust.
Moving forward, all the medical device software developers, regardless of SW risk, must provide most of the software documentations (including complete SRS, architecture design chart, risk management file etc.) in the premarket submission as a minimum requirement.