Device group urges FDA to refine software function guidance

Regulatory NewsRegulatory News
| 14 February 2022 | By Joanne S. Eglovitch 

The Advanced Medical Technology Association (AdvaMed) urged the US Food and Drug Administration (FDA) to refine its draft guidance on device software in premarket submissions, asserting that requiring enhanced documentation for certain types of devices is problematic; while GE Healthcare called for greater clarity on how FDA determines whether a device should be subject to basic or enhanced levels of documentation.
Other comments included expanding the scope of the draft guidance to include new drug applications. These comments were in response to FDA’s draft guidance on device software functions in premarket submissions, which will replace the agency’s 2005 guidance on the topic when finalized. The guidance outlines principles about the documentation needed to support the agency’s evaluation of device software functions for premarket submissions. (RELATED: FDA issues draft guidance for device software in premarket submissions, Regulatory Focus 4 November 2021)
The draft specifies that the agency will consider whether software needs a basic or enhanced level of documentation. It specifies that enhanced documentation should be provided by the sponsors if the device falls in one of the categories: if the device is a class III device; presents a risk of serious injury or death for stakeholders; the device is a “constituent part of a combination product,” or the device is “(a) is intended to test bloods donations for transfusion-transmitted infection; or (b) used to determine donor and recipients compatibility: or (c) is a Blood Establishment Computer Software.”
AdvaMed takes issue with enhanced documentation factors
AdvaMed disagreed with the factors FDA listed in the guidance that would necessitate enhanced documentation. AdvaMed said the guidance fails to follow a risk-based approach as it would subject some devices to enhanced documentation based on the device’s intended use rather than the device function’s risk.
The group said that “simply because a software function may be a constituent part of a combination product, used with blood screening assays, or a component of a class III device, does not mean that the software contributes significantly to the overall risk of that device.”
The group suggested that “with respect to determining the appropriate documentation level, the draft guidance should be consistent in stating that the risk of the device software function – and not the risk of the overall devices – should be the driving factors. Grounding the documentation on the risk posed by the software is consistent with ANSI/AAMI/IEC 62304:2006/A1: 2016 (‘IEC62304’).”
AdvaMed also calls for FDA to provide a 90-day transition period once the guidance is finalized to allow device makers to continue to submit software documentation in accordance with the agency’s 2005 guidance.
GE Healthcare suggested that FDA provide clarity on how the basic or enhanced level of documentation is determined and requested more examples that “span a broader range of devices.”
PhRMA: Not all combination products should require enhanced documentation
The Pharmaceutical Research and Manufacturers of America (PhRMA) recommended the scope of the guidance be expanded to include new drug applications, asserting that failure to include NDAs “could lead to regulatory divergence across the Centers.”
The group also said that not every combination product should require an enhanced documentation level and strongly urges the agency to revise the draft guidance so that this requirement "is not automatic.”


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