FDA Proposes Approach for Regulating Certain Mobile Health Care Applications

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The Food and Drug Administration has proposed an approach for how it will oversee software applications designed for use with smartphones and other mobile devices for health care purposes.

In a draft guidance document published online July 19, FDA said it was seeking comments on its proposal for overseeing two subsets of mobile medical applications—software applications used as accessories to medical devices already regulated by FDA, and applications used to transform mobile devices into regulated devices.

Bakul Patel, policy adviser in FDA's Center for Devices and Radiological Health, said during a briefing with mobile health industry stakeholders that the guidance was not intended to cover most applications in the mobile health marketplace, but only those used with or to create medical devices already covered by existing FDA regulations.

Patel noted that FDA already has cleared a handful of mobile health care applications and that the proposed guidance was part of the agency's effort to work with applications developers to create the best pathway for mobile health care apps.

He encouraged applications developers and device manufacturers to submit comments on the proposed oversight approach so that FDA could strike the right balance between innovation and patient safety for mobile health care applications. The agency is asking for comments within 90 days. The agency is expected to publish a notice seeking comments in the July 21 Federal Register.

Patel also clarified that FDA does not intend now or in the future to regulate the general use of smartphones, tablets, and similar mobile computing devices.

Mobile Medical Application Defined

In its proposed guidance, FDA defined mobile medical applications as those meeting the definition of a device under the Federal Food, Drug, and Cosmetic Act and falling into one of the two subsets of applications covered by the guidance—an accessory to a regulated device, or used to transform a mobile platform into a regulated device.

FDA further noted that the intended use of a mobile application determines whether a product is considered a device.

“[I]ntended use may be shown by labeling claims, advertising materials, or oral or written statements by manufacturers or their representatives,” FDA said in the guidance. “When the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device.”

For example, a mobile software application that operates a light emitting diode (LED) on a mobile platform—such as a tablet—would not be covered by the proposed FDA oversight authority if operation of the LED was intended for general purpose use. However, if the mobile app that operates the LED is marketed, promoted, and distributed to operate the LED as a light source to examine patients, then the application would meet the definition of a device and would be covered by the proposed oversight authority.

Device Classifications

FDA said in the proposed guidance that the mobile medical applications that would be subject to regulatory oversight must meet requirements associated with their applicable device classifications, meaning mobile medical apps would fall into one of the three existing classifications for medical devices: class I (lowest risk, general controls); class II (special controls in addition to general controls); and class III (highest risk, needing premarket approval).

Patel said during the stakeholder briefing that FDA was not seeking to require all mobile medical apps be subject to premarket review and approval.

FDA specifically requested comments on the approach it should it take for overseeing mobile medical apps that are accessories to other medical devices because of the variety of functions a single application could perform.

“The FDA has typically expected that the manufacturer of an accessory would meet the requirements associated with the classification of the connected device. However, this approach may not be well-suited for mobile medical apps that serve as an accessory to another medical device because of the wide variety of functions mobile medical apps can potentially perform,” FDA said in the proposed guidance.

Among the examples FDA listed as mobile apps over which it would exercise authority are:

• apps used for displaying, storing, analyzing, or transmitting medical device data, such as remote displays of data from bedside monitors and displays of medical images directly from picture archiving and communication system servers;

• apps used to control medical devices via mobile platforms, such as those that can control the inflation and deflation of a blood pressure cuff and those that can control the flow of insulin on an insulin pump; and

• apps used as part of clinical decision support tools, such as those that provide a questionnaire for collecting patient-specific data and then use the data to compute the prognosis for a particular condition or disease or provide recommendations to clinicians for diagnosing or treating patients.

Some Apps Not Covered

Attorney Keith Barritt, with Fish & Richardson PC in Washington, told BNA that among mobile apps not covered by the proposed FDA guidance are electronic versions of textbooks and teachings aids, diet tracking software, exercise software, and personal health records.

Barritt also said FDA was not seeking in the proposed guidance to oversee entities that merely distribute mobile medical apps.

FDA cautioned that the proposed guidance was not intended to cover all mobile health products for which it could exercise oversight authority and that for some products it would issue similar guidance in the future.

Welcomed Guidance

The mobile health care industry has urged FDA to provide clarity on how it will regulate mobile health care products.

“The FDA draft guidance document is a very welcome step in the evolving regulation of mobile apps, as currently there is much uncertainty and confusion in the marketplace as to when FDA jurisdiction kicks in,” Barritt said.

Attorney Bradley Merrill Thompson, with Epstein Becker & Green PC in Washington, told BNA that while the proposal is “fairly narrow,” apps developers may be caught off guard by some of the types of applications covered by the guidance.

For example, he said, clinical decision support software applications were not necessarily on developers' radar screens as potentially being covered by the FDA guidance.

Nevertheless, other categories of apps to which the guidance would apply do not come as surprise, he noted, such as apps that are accessories to already-regulated medical devices.

Thompson, who is a founder of the mHealth Regulatory Coalition, which is drafting guidance documents it will submit to FDA on ways for regulating mobile health products, said that FDA's proposal provides some clarity on oversight issues, but does not answer all the questions the mobile health industry has about FDA regulatory authority over the mobile health products.

For example, he said, FDA did not address questions raised by mobile health product developers about determining the intended use for products that are in the gray area between regulated medical devices and products that clearly do not meet FDA definitions for regulated products.

“We want more clarity about intended use,” Thompson said.

The guidance also did not address industry concerns about how the accessory rule is applied to products that developers believe should not be regulated in the same category as the medical device to which they are attached, Thompson said. Thompson's group raised issues related to the way FDA applies the accessory rule in a proposed draft of suggestions for FDA it will send to the agency later this year. It noted that in certain situations, FDA regulates a product that is an accessory to a medical device as if it is in the same regulatory classification as the “parent” device.

For some accessories, including some mobile health products, regulating them at the same level as the medical devices with which they are used is “overkill,” Thompson said, and FDA could consider “down classifying” them.

Thompson further noted that the mHealth Coalition in its draft guidance to FDA will recommend creating—through rulemaking—separate software classifications that better reflect those products than existing medical device classifications.

By Kendra Casey Plank

The FDA proposed guidance is at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm263280.htm . A prepublication copy of the FDA's Federal Register notice is at http://op.bna.com/hl.nsf/r?Open=bbrk-8jwt3u .