mHealth Reg Coalition creates risk assessment tool for FDA

The FDA needs to loosen up its marketing definitions, be more specific about mHealth accessories, and create a risk profile for mobile software. That's the upshot of comments from the mHealth Regulatory Coalition, released on Friday, on the FDA's most recent mobile medical app guidance.

At the heart of the commentary is an elegant risk assessment tool that MRC members hope the FDA will use to determine the true risk of mobile medical apps, Brad Thompson, FDA expert and MRC member, tells FierceMobileHealthcare. The tool, a color-coded matrix, compares the likelihood of a device's failure (from improbable to frequent) against the severity of the health result from such a failure (negligible to catastrophic).

It's an approach the MRC hopes the FDA will take as it determines into which classifications--Class I, II, and III--to place mobile medical apps, Thompson says. FDA officials have long complained of not being able to keep up with changing software trends, so the MRC's risk-assessment tool may help to "organize software more by enduring functionality categories rather than by features, which change frequently," he adds.

Two other crucial highlights from the document:

Intended use: MRC members are pushing the FDA to ease up on its definition of "intended use." Under the current definition, a product whose marketing materials or descriptions even mention a specific disease-state or condition is likely to be regulated, Thompson explains.

The MRC wants to convince agency officials that apps whose intended use is to provide general, well-established health guidance, such as increased exercise for diabetics, shouldn't be regulated as tightly as apps that provide patient-specific, disease-specific treatment recommendations.

"We think that's overkill. There are a lot of apps for recording calories, exercise, any number of things that are so low-risk, it's really like carrying around a notebook and recording that information," Thompson says.

Accessories: The MRC comments also are asking for a more granular description of which accessories and mobile add-ons are regulated. The FDA's existing guidance is too broad, Thompson says, and basically categorizes any connected accessories in the same regulatory class as the "parent" device. The problem: That applies as strongly to a simple cable that links a glucose monitor to a cell phone as it does to a sophisticated clip-on that turns an iPhone into a microscope.

The MRC is seeking industry comment on its recommendations by Oct. 12, and plans to incorporate any changes into the document before submitting it to the FDA on Oct. 19.

To learn more:
- read the MRC comments (.pdf)

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