By Russell Fox, Communications Practice, Mintz Levin
The FDA’s Role in mHealth
The FDA is authorized to regulate “medical devices” and approve them for use. Medical devices fall into one of three classes:
Class I-simple devices that pose little risk of harm to the user
Class II-devices that are more complex than Class I, but for which data is available to provide assurances of their safety and effectiveness
Class III-devices that entail great risk for the patient and may be capable of sustaining human life.
All three classes of devices are subject to “general” controls, which include certain registration, listing, and labeling requirements, as well as pre-market notification and good manufacturing practices. Class I and some Class II devices are often exempt from the latter two general controls. In addition to the applicable general controls, Class II devices are also usually subject to “special” controls, such as additional labeling, performance standards, and post-market surveillance. Many Class III devices must undergo a more lengthy pre-market approval process.
Under the Federal Food, Drug and Cosmetic Act (the FD&C Act), a medical device is defined to include an instrument, implement, or machine, including a component part or accessory which is used in the diagnosis, cure, prevention or treatment of disease or affects the structure of any body function. The devices that use the spectrum specifically designated by the FCC for these purposes-in the MedRadio, WMTS, and potentially MMN and BSN bands-are also all regulated by the FDA because they perform a medical function.
The FD&C Act’s definition of “device” is broad-it includes everything from simple tongue depressors and bedpans to complex programmable pacemakers and laser surgical devices. Despite this broad definition, not every item used in the diagnosis or treatment of a medical condition is a medical device. For instance, a fax machine used to transmit patient data is not regulated by the FDA. The mere exchange of health information does not constitute diagnosis, cure, prevention, or treatment of disease.
To date, the FDA has approved wireless products as medical devices in two broad categories. The first consists of devices, the primary purpose of which is to measure patient data and transmit it. For example, Motorola’s HealthPal and products offered by CardioNet embed wireless chips in patient data-gathering devices. These devices then transmit patient information to a company or third-party location, where the data is reviewed, stored, and acted on, if required. The HealthPal and CardioNet products are essentially single-purpose wireless transmitter-receivers. Recently, the FDA has determined that at least some mHealth applications used on regular wireless phones are also medical devices. For example, the FDA has approved the “Pill Phone,” a mobile medication reminder software. Similarly, LifeWatch received FDA approval for its Ambulatory Cardiac Telemetry (ACT), which monitors patient data and, when it senses an abnormality, sends that information to a patient’s cell phone, which in turn calls a LifeWatch monitoring call center. In neither case did the wireless carrier making these applications available to its subscribers obtain FDA approval.
So far, at least, the FDA has not ruled that cellphones themselves become medical devices subject to approval if they are running these applications, but at least some FDA officials have speculated publicly that the agency may consider whether such approval should be required. Attention to this issue by the FDA may be hastened by the introduction of new handsets with built-in medical monitoring functionality. These handsets could more closely resemble medical devices than phones with medical applications. Reportedly, LG Electronics has built a cellular handset with a blood glucose monitor embedded in it. The phone displays the glucose metering, keeps track of the results, and sends them to a medical facility. When this equipment reaches the United States, it will likely require FDA approval as a medical device, even though the device is principally a cell phone, which would ordinarily not require FDA approval.
The FDA generally requires manufacturers of devices to secure approval. While it therefore appears that wireless carriers will not be primarily responsible for ensuring that such integrated devices receive FDA approval, carriers may someday need to confirm that the manufacturers whose devices they market have secured all necessary FDA, as well as FCC, regulatory approvals.
* At the same time it designated spectrum in the WMTS specifically for wireless medical telemetry, the FCC said that it would no longer permit the use of other unlicensed bands, where a variety of devices operated, for wireless medical use.
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