FDA needs new regulations to establish product classifications for mobile health accessories and software applications that do not fall within existing agency rules, a mobile health industry group urged in a draft proposal document issued Sept. 29.

“The rapid evolution of mHealth technologies and software system architectures poses a significant challenge” to guidance development, the mHealth Regulatory Coalition argues in the document, which the coalition is developing as a proposed guidance it plans to submit to FDA later this month.

The coalition suggests FDA apply general principles to future mHealth technologies to determine whether they fall within the scope of the agency’s existing product classifications and exemptions.

FDA Guidance Already In Progress

FDA is already taking public comments through Oct. 19 on a draft guidance outlining the agency’s current mHealth policy. (See “ Also see "Industry Applauds FDA Draft Guidance On Mobile Medical Apps" - Medtech Insight, 25 July, 2011. ” – “The Gray Sheet” July 25, 2011.)

When finalized, the guidance is intended to help device firms and mobile app developers determine whether their mHealth products will face regulation, and if so, under what classification.

Some software, for example, would be exempt from pre-market notification procedures but would still be required to comply with general controls such as quality systems.

However, the mHealth coalition cautions that formal classification systems do not yet exist for every type of mobile software and related accessories.

“We believe that FDA needs to engage in rulemaking to develop new classifications for accessories and mHealth software,” the coalition reports, although it adds it is not proposing a new classification scheme specific to mHealth products.

Rather, it says, “our proposal tailors the existing regulatory framework to mHealth products, including identifying a number of product types that might fall within an mHealth system for which there does not currently exist a classification regulation.”

The Sept. 29 draft proposal brings together several prior draft documents targeting device accessories, software issues and intended use claims as they relate to mobile health products. (See “ Also see "Industry Explores FDA Risk Classifications For Mobile Health Devices" - Medtech Insight, 23 May, 2011. ” – “The Gray Sheet” May 23, 2011.)

The industry group is seeking public comment through Oct. 12 to help fine-tune the document for submission to FDA as a formal proposed guidance. The coalition also plans to submit a separate comment letter on FDA’s own mobile health draft guidance.

Accessory Regulations Present Complications

The industry proposal says FDA may need to clarify and reconsider how it will establish appropriate regulatory oversight for device accessories as a result of the “inherent interconnectedness” of mobile health products.

mHealth Risk Considerations

Product functionalities that help inform the level of risk associated with a mobile health device or app:

Data display
Alarm generation
Virtual control allowing another product within the system to operate the device
Automatic control activated according to pre-determined algorithms
Programming control based on clinician-established algorithms

As future products are marketed with broad systems claims rather than one-to-one pairing claims, the draft proposal adds, the questions promise to become more complicated.

The proposal asks FDA to publish classification regulations for commonly used accessories, defining generic families of accessories and then regulating them based on claims of compatibility between accessories in a family and the data-generating medical devices to which they connect.

Firms making the interoperability claims would not only be required to provide adequate support for the claim but also some assurance that the claim would remain true over time.

“Future substantiation consists of the establishment of a quality system and on-going validation testing whenever changes to either article are made,” according to the proposed language. “This may involve either control of the design of both devices (e.g., by ownership) or an agreement between the claim maker and the manufacturer of the product that design specifications will not change or that notifications will be given in advance of any changes to allow the claim maker to adequately address the impact of such changes on the future substantiation of the claim.”

The coalition also suggests that mobile apps developed for a proprietary mobile health device could be less risky than one used on a general-purpose smart phone because the latter option “involves features and functions that are not specific to the software app, but that may cause the software app to malfunction.”

In turn, proprietary hardware with design features limited to the specific intended use and functionality of a given software application “should involve less risk,” the group argues.

Meanwhile, the proposed draft suggests that mHealth software that takes advantage of cloud computing platforms – where data storage or processing tasks for a software application are distributed among multiple remote computer networks – should not be viewed as inherently more risky than those run on dedicated hardware. (See “ Also see "Cloud Computing Could Complicate Efforts To Clarify Mobile Health Regulation" - Medtech Insight, 18 July, 2011. ” – “The Gray Sheet” July 18, 2011.)

Intended Use Claims And The Public Good

One key component of industry’s draft proposal is that FDA would not regulate intended use claims for mHealth applications in which the perceived social benefit outweighs an inherent low risk.

In particular, this refers to health and wellness claims that could serve as a “powerful education tool for consumers to learn about the benefit of lifestyle and behavioral modification,” the document notes.

Ambiguous Terms

These words should not automatically trigger FDA regulation in an intended use claim for mobile health apps, the mHealth Regulatory Coalition says:

Health, wellness or well-being
Satisfaction or happiness
Heart health
General health
Overall health
Unhealthy
Stress or stress management
Hospitalization
Challenge or game
Personal use
Non-diagnostic-quality
Sleep deprivation

To be exempt from regulation, the proposal cautions, claims for the products in question should be generally recognized as a health rather than a disease claim; qualify the claim with language such as “may” or “might;” and specifically not involve invasive procedures.

Examples of a claim that might be considered exempt under this scenario: “A software app that may reduce the risk of heart disease by actively monitoring and trending exercise activity on a daily basis” or “A cloud-based personal health storage system that may improve your quality of life by allowing friends and family to review your behavioral activities in order to support you in your effort to quit smoking.”

The coalition also argues that information claims related to collecting data or providing alerts about non-acute conditions should be exempt. One condition of meeting this exemption would be that the collected information could not be transferred to or have any control over a medical device.

An example in this category might be, “A sensor system and smart phone app for use by a school nurse to monitor and alert the user of allergens in the school cafeteria and/or air pollen/pollutants on the school playground,” the document describes.

The coalition also offers guidance on considering inherent risk in claims involving ambiguously defined but low-risk products. (See box, “Ambiguous Terms.”) To be eligible for exclusion, the intended use claim must not be a disease claim and must not be used to specifically help diagnose, prevent or treat a disease.

By Monica Hogan

New Rules Needed To Classify mHealth Products, Says Industry Coalition

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