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Device group calls on FDA to further refine it’s the guidance on software functions

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The Advanced Medical Technology Association (AdvaMed) has urged the US FDA to revise its draft guidance for devices software included in premarket submissions, saying that the requirement of more detailed documentation for specific types of devices can be problematic. In addition, GE Healthcare called for greater clarification on how the FDA decides if a device must be subject to the standard or more detailed documentation standards.

 Other comments also included expanding the range of the draft guidance to cover new applications for drugs. These remarks came in the wake of the FDA's draft guidance on devices' software functions in premarket submissions. The guidance can replace its guidance from 2005 regarding the subject once the guidance is finalized. The direction provides guidelines for the documentation required to support the agency's assessment of the functions provided by devices in premarket submissions.



The draft states that the agency must consider whether software requirements are a basic or more detailed degree of documentation. It specifies that the sponsors should provide enhanced documentation 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 blood donations for transfusion-transmitted infection, or (b) used to determine donor and recipients compatibility: or (c) is a Blood Establishment Computer Software.”


AdvaMed has a problem with the enhanced documentation aspects.

AdvaMed did not agree with the reasons FDA has listed in its guidance, which would require more documentation. AdvaMed claimed that the guidance does not seem to adhere to a risk-based method because it could subject certain devices to more detailed documentation following the purpose of the device rather than the device's function's risk.

 The group stated that “simply that a software feature might be an integral part of a combined product that is used in conjunction with blood screening tests or is a component of an instrument of class III, doesn't mean that the software is contributing significantly to the risk of the device.”

 The group recommended that “with regard to determining a proper level of documentation the draft guidance must be consistent in saying that the risk posed by the software functions of the device and not the overall risk of devices should be the primary driver. The documentation should be based on the potential risk of the software is in line with ANSI/AAMI/IEC62304:2006/A (‘IEC62304:2016'). (‘IEC62304 ‘).”

 AdvaMed is also calling for the FDA to grant the 90-day transition period after the guidance is approved for permitting device makers to continue submitting documentation for software according to the agency's 2005 guidelines.

GE Healthcare suggested that the FDA clarify what the fundamental or advanced document level is decided and demanded additional examples that “span the full variety of equipment.”

The Pharmaceutical Research and Manufacturers of America (PhRMA) suggested that its guidelines be expanded to include all new drug applications, stating that the absence of NDAs “could result in regulatory divergence between the Centers.”

The group also noted that not all combination products require a more detailed documentation level and strongly encourages the agency to update the draft guidance to ensure it is clear that the need “is not an automatic requirement.”


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