Device group urges FDA to refine guidance on software features

Posted on February 14, 2022 | By Joanne S. Eglovitch

The Advanced Medical Technology Association (AdvaMed) has urged the US Food and Drug Administration (FDA) to refine its draft device software guidelines in premarket submissions, saying it is problematic to require improved documentation for certain types of devices; while GE Healthcare called for more clarity on how the FDA determines whether a device should be subject to baseline or enhanced documentation levels.

Other comments included expanding the scope of the draft guidelines to include new drug applications. The comments were in response to the FDA’s draft guidance on device software functions in premarket submissions, which will replace the agency’s 2005 guidance on the subject when finalized. The guidelines outline principles for the documentation needed to support the agency’s evaluation of device software functions for premarket submissions. (RELATED: FDA releases draft guidelines for device software in premarket submissionsRegulatory guidance November 4, 2021)

The draft specifies that the agency will consider whether the software needs a basic or enhanced level of documentation. It specifies that enhanced documentation must be provided by sponsors if the device falls into one of the following categories: if the device is a class III device; poses a risk of serious injury or death to responders; the device is a “component part of a combination product”, or the device is “(a) is intended to test donated blood for infection transmitted by transfusion; or (b) used to determine the compatibility of donors and recipients; or (c) is blood establishment computer software. »

AdvaMed challenges enhanced documentation factors

AdvaMed disagreed with factors listed by the FDA in the guidelines that would require improved documentation. AdvaMed said the guidelines do not follow a risk-based approach because they would subject certain devices to enhanced documentation based on the device’s intended use rather than the risk of the device’s function.

The group stated that “the mere fact that a software function may be a constituent part of a combination product, used with blood screening tests, or a component of a Class III device, does not mean that the software contributes significantly to the overall risk of this device”. .”

The group suggested that “with regard to determining the appropriate level of documentation, the draft guidance should be consistent in stating that the risk of the software function of the device – and not the risk of the entire devices – should be the deciding factor. Software risk documentation grounding conforms to ANSI/AAMI/IEC 62304:2006/A1:2016 (“IEC62304”).

AdvaMed is also asking the FDA to provide a 90-day transition period once the guidelines are finalized to allow device manufacturers to continue submitting software documentation according to the agency’s 2005 guidelines.

GE Healthcare suggested the FDA provide clarification on how basic or enhanced level of documentation is determined and asked for more examples that “cover a broader range of devices.”

PhRMA: not all combination products should require enhanced documentation

The Pharmaceutical Research and Manufacturers of America (PhRMA) recommended that the scope of the guidelines be broadened to include new drug applications, saying failure to include NDAs “could lead to regulatory divergence between centers.”

The group also said not all combination products should require an enhanced level of documentation and urges the agency to revise the draft guidelines so that this requirement “is not automatic”.


© 2022 Society of Regulatory Affairs Professionals.

Comments are closed.