FDA Asks For Input From Clinicians About Mobile Apps In Medicine
The publication in July of the FDA Draft Guidance on mobile medical apps was a major milestone in the evolution of mobile medicine. The blazingly rapid growth in interest among physicians, medical software publishers and device manufacturers has made it clear that the mHealth revolution will be a major turning point, not just in health information technology, but likely in many aspects of physician-patient interactions.
Last week (Sep 12-13), the FDA is held an important public workshop near its Washington DC headquarters to help it answer some key questions raised within the Draft Guidance and gather feedback from important stakeholders in mobile health. We are proud that iMedicalApps was invited to participate as one of the panelists.
We want to hear from you iMedicalApps readers – what do you want the FDA to consider in regulating mobile medical apps ?
Please add your voice in the comment section below and we will assemble them for submission to the official FDA docket on the Draft Guidance. Hurry because the deadline is just a few weeks away.
The FDA needs input from clinicians and others interested in mobile medicine and has identified two topics in particular as needing further specification:
- How to assess the risks inherent to clinical decision support software and
- How to classify mobile software that works in concert with a medical device.
We recently had the opportunity to speak with Bakul Patel, MSEE, MBA, the lead author at the FDA of the Draft Guidance, about the Workshop. Mr. Patel combines a focused interest in mobile software with a broad background in business and technology to bear on this issue. He pointed out that developing this particular guidance was more intricate than many others since it had to be cleared by not only our center and the larger FDA but also our parent agency, the HHS. Even the Office of Management and Budget in the White House expressed an interest due to the possible economic impact….as soon as you touch something like “mHealth”, more entities get involved.
It must be remembered, though, that this process will eventually produce a guidance, not new regulations. The distinction is an important one. A guidance provides principles on how the FDA intends to apply existing regulations. Therefore, once the Draft Guidance is finalized, medical software publishers and device makers should be able to predict what types of apps the FDA believes require pre-market clearance and whether they will likely be considered Class I, II or III devices. This will be very valuable for the continued development of mHealth devices and software.
In contrast, regulations have the force of law. The rule making process can be very time consuming since often numerous disparate outside comments are incorporated into the final rules. For example, the regulation designating Medical Device Data Systems (MDDS) as Class I devices was proposed in 2008 but finalized only in 2011 (see our previous post for details about MDDS).
Nevertheless, producing the Draft Guidance is painstaking work, as Mr. Patel explained, because you’re making national policy and that the document has to be legally sound while addressing the different audiences, including lawyers, users, doctors, manufacturers and the medical device industry. Convening a two day workshop on mobile medical apps is a sign of the importance the FDA has placed on this topic.
Mobile Apps as Accessories
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