Sep 14, 2011
Can minimally-staffed software application developers getting into the medical device sector reasonably be expected to comply with the same FDA requirements as medical device manufacturers?
That was one issue addressed during the FDA’s quality management systems in order to satisfy FDA requirements.
But app developers targeting the US medical device market had better prepare for just such a requirement, according to AdvaMed director of technology and regulatory affairs Bernie Liebler. “What do you have in place to guarantee software quality?” he argued. “It’s very difficult—even after validation, software can be buggy.”
Liebler suggested that requiring software developers to have quality systems in place or abide by some kind of recognized standard would not be unreasonable, echoing the FDA’s guidance recommending that “all manufacturers of all mobile apps that may meet the definition of a device follow the Quality Systems regulations (which include good manufacturing practices) in the design and development of their mobile medical apps and initiate prompt corrections to their mobile medical apps, when appropriate, to prevent patient and user harm.”
Just such an approach was taken by MedApps, a remote health monitoring technology developer. MedApps CEO Kent Dicks explained that his firm undertook quality system implementations not only to meet potential regulatory requirements but also (and just as importantly) to attract investors.
Going forward, medical app developers aligning their products more closely with medical devices had best get used to the idea of quality system implementation, both to satisfy regulators and effectively raise capital.
Mobile medical app-related issued explicitly not covered by the recent FDA guidance’s scope include wireless safety, applying quality systems to software and regulatory requirements for clinical decision support (CDS) software. The agency has disclosed plans to address these issues in separate guidances, but has provided no further details on those plans.
During the US Food and Drug Administration’s two-day public workshop on its Mobile Medical Applications Draft Guidance held September 12 and 13, 2011, attendees and FDA officials wrestled with the issue of how to classify applications that serve as accessories to medical devices.