This summer, the FDA issued a draft guidance document addressing how the agency intends to apply its regulatory authority to Mobile Medical Applications (MMAs). The guidance document defines mobile applications as “software applications that can be executed (run) on a mobile platform,” which includes tablet computers, smart phones, and personal digital assistants (PDAs). To be considered an MMA, however, the mobile application must first meet the definition of “device” under section 201(h) of the Food, Drug & Cosmetic Act and either:
- Be used as an accessory to a regulated medical device; or
- Transform a mobile platform into a regulated medical device.
Many critics of the FDA draft guidance document complain that the guidance does a poor job at drawing a line between regulated and unregulated MMAs. For example, many point out that the FDA’s intention to regulate mobile applications that “allow the user to input patient-specific information and – using a formulae or processing algorithms – output a patient-specific result,” could include algorithms like BMI calculators that patients can find through a simple online search engines. At first glance, it does seem absurd that the FDA would take it upon itself to regulate all such online formula or algorithms. But the critics are overstating here – the FDA is not concerned that a patient may, out of curiosity, decide to use a BMI calculator to determine whether or not their weight falls within a healthy range. In fact, the FDA stated it has no intention to regulate “mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness.” The real concern here seems to be that clinicians might use these apps when “making a diagnosis or selecting a specific treatment for a patient.”
But what if it is the clinician who decides to use a BMI calculator when diagnosing his or her patients? In this scenario, then, it does make sense to question why an MMA should be treated any differently than a website that contains the same information, and the FDA draft guidance does little to clear up. In any case, the draft guidance does put forth several examples of MMAs it does not intend to regulate, as well as a list of examples “devices” and MMAs in Appendix A that it has decided to regulate, in order to give readers a better idea of what the FDA has in mind. An overview of this list leads to the conclusion that the FDA intends to regulate those MMAs that are:
- (1) Used by clinicians; AND
- (2) Intended to treat, cure, or diagnose a patient with a disease or condition; OR
- (3) Extensions of an already regulated medical device; OR
- (4) Used for displaying, storing, analyzing, or transmitting patient-specific medical device data.
While these factors seem to fit the FDA’s goal of only regulating a “narrowly-tailored” subset of MMAs, it is clear that the agency’s final rule will have to do a much better job at defining those applications it considers to fall within its regulatory scope, as a simple list of examples will still leave many mobile application developers scratching their heads.
That the FDA is really only concerned with applications used in a clinical setting is even further evinced by the fact that the FDA recently refused to get involved in a case concerning two mobile health application developers who falsely claimed that their applications could treat acne by emitting colored lights.1 Instead, it was ultimately the FTC that reached a settlement agreement with the companies, ordering them to pay (collectively) $15,994.00 and to stop making baseless claims about their products. Many wondered why the FDA decided not to get involved in the case, since it clearly had authority to regulate. Some opined that it might be a sign the FDA is waiting to reach a final decision on the issue before taking an enforcement action, while others attributed it to the fact that the FDA may not have the resources to enforce these types of cases at this time.3 Or, as stated above, it could simply be that the FDA is not that concerned about regulating MMAs that are used outside of a clinical setting. If the FDA decided to regulate every teenage prank that manifested itself as a mobile application, then it would definitely not have the resources to target those applications that truly pose a danger to public health (although comments from users that the app “really worked!” does leave one wondering whether the FDA should regulate some of these sophomoric applications). In any case, it was significant that the FTC stepped in to help regulate, as this may be a sign that the agencies plan to work together in the future to prevent mobile app developers from making false health claims about their products.4
Although the FDA’s draft guidance document is a little vague on some of the finer points, the FDA plainly acknowledges in its opening paragraphs that the document only reflects “the Agency’s current thinking on a topic and should be viewed only as recommendations.” Still, there are more than a few remaining practical concerns. First, some apps that are not “medical devices” under the FD&C Act may still pose a risk to public health.5 Second, there may still be some uncertainty for mobile application developers new to FDA regulations, as the guidance document provides a series of controls that developers should follow. This uncertainty and increased burden could lead to a chilling effect on the further development of MMAs. Finally, since this is a field that continues to grow exponentially, there is a definite concern that even with a narrowly tailored focus the FDA will be unable to respond quickly to new technologies.
For a handy guide to the FDA’s draft guidance document, look here.
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1. FDA’s Deferral to FTC on MHEALTH Enforcement Raises Questions, FDA Week (Inside Wash. Publishers, Arlington, VA), Sept. 16, 2011, available at http://healthpolicynewsstand.com/FDA-Week/FDA-Week-09/16/2011/menu-id-315.html.
2. Id.
3. Id.
4. Id.
5. MHEALTH Advocates Press FDA to Consider Risk in Assessing Apps, FDA Week (Inside Wash. Publishers, Arlington, VA) Sept. 16, 20011, available at http://healthpolicynewsstand.com/FDA-Week/FDA-Week-09/16/2011/menu-id-315.html.