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The Food and Drug Administration (FDA) has published draft 510(k) guidance that aim to update premarket notification practices for medical devices. Released on Dec. 27, 2011 with a 120-day comment period, this 510(k) guidance would supersede documents released in 1986 and 1998.
When coupled with the medical device data system (MDDS) final rule released last year, which reclassified devices that merely store or transfer data, as well as draft guidance on mobile health applications, the 510(k) guidance should streamline the process by which medical devices are approved.
Whether it will clarify the question of how the FDA will regulate mHealth remains to be seen. As mobile health’s value proposition continues to climb, concerns abound that regulation will stifle innovation, particularly among application developers within hospitals (who may suddenly be subject to FDA rules) and small tech startups (who may run out of funding long before the 510(k) premarket notification process concludes).
At the moment, it seems that the bulk of mobile health applications, which collect data but do no harm to a patient (think wellness apps), would essentially be considered Class II devices under the 510(k) guidance. This means that no 510(k) premarket notification is required, though the FDA can implement special controls such as performance standards or post-market surveillance.
While FDA mobile health regulations won’t necessarily be directly tied to 510(k) guidance, the two sets of rules will have to intersect in some way. How much they do will go a long way toward defining the future of mobile health development.