Devices

Draft FDA Software Guidance Raises Questions

Attorneys Michele Buenafe and M. Elizabeth Bierman (Morgan, Lewis & Bockius) say there are questions raised by an FDA 10/14 draft guidance on clinical evaluation of software as a medical device (SaMD). The guidance was developed by the SaMD working group of the International Medical Device Regulators Forum (IMDRF). The attorneys say this is the first time FDA has proposed issuing an IMDRF document as an official FDA guidance document. Writing in the National Law Review, they outline three key takeaways:

Since FDA has not yet issued its long-promised draft guidance on clinical decision support software, there is no clear overarching policy on when software used for health- or medical-related purposes would be considered software as a medical device subject to FDA regulation. The attorneys say that issuing guidance on agency expectations for the clinical evaluation for SaMD seems premature. “Software developers need to first understand where the proverbial line is before investing in clinical evaluation activities,” they write.
Although the draft uses terminology defined in other IMDRF documents and incorporates by reference findings from other IMDRF documents, FDA has not officially adopted those other IMDRF documents as agency guidances. “It is not clear whether FDA intends this draft guidance to be the first volley, followed up by formally issuing other IMDRF documents on SaMD as FDA guidances, or whether FDA would simply consider the terminology and principles in those other IMDRF documents to be adopted by proxy if and when it finalizes this draft guidance,” the article says. “It also is not clear how the principles and terminology in these other IMDRF documents align with FDA’s existing regulations and guidance documents.”
Although the draft guidance’s focus is SaMD, the attorneys write that a significant part of its 45 pages is devoted to definitions, general principles, context, and SaMD categorization principles, as well as to references to other IMDRF documents, the attorneys say. Only one section directly addresses clinical evaluation, which it describes as the process for establishing the scientific validity, analytical validity, and clinical performance of an SaMD.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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