FDA Issues Final Guidance On Mobile Medical Apps: Black and White, and Gray

As has been heavily reported, the U.S. Food and Drug Administration has issued its final guidance for developers of mobile medical apps, which are software programs that run on mobile communication devices and perform the same functions as traditional medical devices. The guidance outlines the FDA’s approach to mobile apps.

According to the agency’s release, it intends to exercise “enforcement discretion” (meaning it will not enforce requirements under the Federal Drug & Cosmetic Act) for the majority of mobile apps as they pose minimal risk to consumers.

The FDA says it intends to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended.

Even though some guidance is offer (loosely below), does this not create a slippery slope type of situation? The mobile app market is vast and it is ever changing, literally every day there are new advancements. Give then overwhelming changes, why is the government so confident in its assumption that this rule – now set in stone – will remain relevant with the ever present changes facing the mobile tech and app markets?

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