"The majority of the folks who I've been dealing with do fall within the scope of that guidance document," said Bradley Thompson, a New York attorney specializing in medical device regulation.
Examples of mobile apps that FDA may regulate to protect patient safety include:
-- Mobile apps that allow the remote use of one or more medical devices by controlling them or displaying, storing, analyzing, or transmitting patient-specific medical device data. This would apply, for example, to remote displays of data from bedside monitors, ECG waveforms, and medical images generated by PACS systems. The mobile apps might also control devices such as a blood pressure cuff or an insulin pump.
-- Software that transforms the mobile platform into a medical device by using attachments, display screens, or sensors, or by including functionalities similar to those of currently regulated medical devices. Examples include apps that turn mobile devices into electronic stethoscopes, glucose meters, or accelerometers for capturing sleep data.
-- Mobile apps that can be used to provide clinical decision support after users input patient data. According to the FDA guidance, this would specifically apply to programs such as those that help clinicians reach a diagnosis or calculate a dosage for a medication.
Thompson interprets the latter category as also encompassing consumer applications. For example, he said a smartphone app might allow users to enter their blood pressure, blood glucose, and other data, and make recommendations about exercise and diet.
"If you're just managing your fitness, it's not regulated," he pointed out. "But if you use it to help manage your diabetes and to coordinate with your physician so the physician can help manage your diabetes, suddenly you're in a different territory. It's not connected to a medical device, but you've made it a medical device because it's decision support software."
The guidance also extends to home monitoring devices, some of which are already regulated. "If you connect directly to a home monitoring device, it's a [regulated] accessory to the device," Thompson said. "If the patient puts the data in manually, depending on how it's used and whether the patient shares the data with a physician to help manage his or her health, the app might be FDA-regulated."
The FDA guidance excludes general wellness and fitness applications from the stricter Class II and Class III regulations, but they must still meet Class I rules that govern registration, labeling, and quality control. In addition, a number of physician apps are excluded, including online medical reference programs, electronic health record and personal health record apps, and billing and other administrative tools.
If a mobile app is regarded as an "accessory" to a medical device, the guidance says, it will be regulated in the same category as the device itself. But the FDA also opened the door to certain applications being regulated at a lower level if they are accessories, Thompson noted. Device makers, he said, believe it's "overkill" to classify mobile accessories to Class III devices such as pacemakers and defibrillators in class III. The FDA is soliciting comments on this issue.
The agency has already "cleared" several mobile apps related to medical devices. These include patient monitoring mobile apps that are classified as cardiac monitoring software, an automatic electronic blood pressure monitor, and a perinatal monitoring system.
Manufacturers of mobile apps that come under FDA regulation may be required to show that their apps work as well as non-mobile software already being used in healthcare settings. But Thompson doesn't think that will drive many firms out of business.
"I'd hope that anyone entering this market would realize that, just because you're operating in a home setting doesn't mean that safety and effectiveness isn't equally important," he said. "I don't think that will surprise a lot of folks."
On the other hand, he pointed out, when FDA issues regulations on mobile health apps, investors will be more likely to support mobile apps, because they will have more certainty about what's required and what their rate of return might be.
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