While the intent of the guidance was to target a small group of mobile medical apps that turn mobile devices into diagnostic medical devices, it also raised questions-and concerns-about subjecting a rapidly evolving health information technology market to the arduous process that drug and medical device manufacturers have dedicated entire departments to managing since the 1938 Food, Drug and Cosmetics Act was enacted.
Today the iTunes store alone has approximately 9,000 consumer-focused mobile health applications and 4,000 targeted to health care professionals.
Those numbers are projected to grow to 13,000 and 6,000, respectively, this year provided the regulatory environment does not change drastically, according to Brian Dolan at mobihealthnews.com.
The mobile medical apps for providers range from study aids for medical students, such as the USMLE Wiz 2 Flashcards by Current Clinical Strategies Publishing, to applications such as the ThinkLabs Stethoscope app, which is designed to enable a mobile device to capture and display heart and lung sounds, among other types of body sounds.
In FDA-speak, medical devices, and now most likely their related mobile medical applications, are classified according to the risk they pose to the patient, and with greater risk comes greater regulatory potential.
Class I devices, such as an elastic bandage or exam gown, pose little risk to a patient. Class II devices, such as a glucose monitor or radiologic imaging device pose moderate risk and Class III devices, such as a drug eluting stent or intravascular catheter, pose the greatest risk to a patient if not manufactured according to best practice manufacturing standards.
Many of the Class I, and some of the Class II devices, are exempt from the FDA's Premarket Notification 510(k) process, but those that are not can submit a 510(k) if they are substantially equivalent (SE) to a legally marketed, or predicate device, not subject to a Premarket Application (PMA).
The cost of a 510(k) submission for FY2012, according to www.fda.gov, is $4,049, or $2,024 for a small business with less than $100 million in gross receipts or sales. Class III devices are most often subject to the PMA process, a more extensive and costly process when evaluating from the perspectives of time, money and manpower. The standard fee for a PMA in FY2012 is listed at $220,050, and $55,013 for a small business.
While many mobile medical apps don't pose any obvious risks to patients, it isn't always easy to separate the wheat from the chaff of what is now the growing crop of app developers and products entering the marketplace.
A medical student who is erroneously taught incorrect anatomy or medical Spanish via an app would most likely fail a test long before touching a patient. But developers entering the market with mobile medical apps that interpret X-ray findings, or calculate test results in order to diagnose or monitor patient information for treatment planning purposes, could have direct impact on patient care.
The FDA has stepped up to regulate this subset of medical apps. What remains unclear is which apps will fall under regulatory auspices and which will remain free of this additional cost burden to their business.
According to a 2011 study by Manhattan Research on the use of mobile devices and technology by U.S. physicians, 81 percent of the more than 2,000 survey respondents owned a smartphone in 2011, compared with 30 percent in 2010, and more than half used a mobile medical app for professional purposes in 2011, compared with one-third in 2010.
No smooth ride
Mark Cain, chief technology officer at MIM Software Inc., has been through the FDA regulatory process with the company's MobileMIM application, and the process went anything but smoothly.
A journey that began in August of 2008 with its first 510(k) submission finally ended with FDA clearance on Feb. 4, 2011. The app provides mobile access to display SPECT, PET, CT or MRI scans for diagnostic purposes when a workstation is unavailable, and was presented in 2008 at Apple's World Wide Developers Conference where it was awarded the 2008 Apple Design Award for Best iPhone Healthcare & Fitness Application.
According to Cain, who has been developing software for medical imaging devices since 2002, MIM Software was already familiar with the regulatory process for medical devices, and was pretty certain the app would fall under the same regulations.
When radiologists who viewed the app confirmed their assumptions, MIM Software made plans to submit a 510(k).
"Unlike the average mobile medical app developer who may not know this world," says Cain, "we are medical device developers. We knew this would be used in the treatment and diagnosis of disease so we knew we could, and should, go to the FDA with a 510(k)."
In summary, the FDA draft guidance issued July 21, 2011, states that a "mobile medical app" is one that meets the definition of "device" in section 201(h) of the Federal Food, Drug, and Cosmetic Act and is either used as an accessory to a regulated medical device, or transforms a mobile platform (iPhone, Blackberry, iPad, etc.) into a regulated medical device.
The FDA defines a device as "an instrument, apparatus, implement ... intended for the use in the diagnosis, cure, mitigation, treatment or prevention of disease in man, or intended to affect the structure or any function of the body of man or animal." And moving forward, disclaimers such as "not for diagnostic use" may not be enough to protect a developer from skirting regulatory responsibilities.
Cain puts it simply, "is it used in the treatment of, or diagnosis of disease? Period. End of story."
As Cain found, knowledge can be power but can also present obstacles others less aware avoid, at least in the short term.