On 19 July 2011, the Food and Drug Administration (FDA or the Agency) issued a draft guidance document clarifying FDA's view on the regulatory status of mobile medical applications for handheld devices.1 The draft guidance, titled Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications, outlines a targeted group of mobile applications over which FDA intends to exercise regulatory oversight. The Agency is seeking comments on the draft guidance by 19 October 2011.
Definition of regulated mobile medical applications
FDA's draft guidance provides several key definitions to explain the type of mobile applications (apps) the Agency is planning to target for regulatory oversight. FDA explains that "mobile platforms" are "commercial off-the-shelf (COTS) computing platforms, with or without wireless connectivity, that are handheld in nature" (e.g., tablet computers, smartphones, PDAs). A "mobile app" is "a software application that can be executed on a mobile platform, or a web-based software application that is tailored to a mobile platform but is executed on a server." According to the draft guidance, FDA only intends to exercise regulatory oversight over "mobile medical apps," which are defined as mobile apps that both meet the definition of a medical device under the Federal Food, Drug, and Cosmetic Act (FDCA)2 and fit into one of two categories:
- apps used as an accessory to a regulated medical device; or
- apps that transform a mobile platform into a regulated medical device.
If the app does not fit into one of these two categories, FDA explains that it intends to exercise its enforcement discretion and refrain from active regulation at this time. Whether an app will meet the definition of a medical device depends on the "intended use" of the device, which FDA will determine from the product's labeling claims, advertising materials, and oral or written statements by manufacturers. When the app manufacturer intends the mobile app to be used "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," then the mobile app would meet the definition of a medical device and, if it fits into one of the categories outlined above, it would be subject to active oversight by FDA.
In an appendix to the draft guidance, FDA provides a list of regulated mobile medical app examples. Some of the listed examples include:
- Apps that connect to DICOM medical image servers and provide processing functions such as pan, zoom, measurement, auto contrasting, automatic detection of features, and other similar functionality.
- Apps that connect to a home use diagnostic medical device such as a blood pressure meter, body composition analyzer, or blood glucose meter to collect historical data or to receive, transmit, store, analyze, and display measurements from connected devices.
- Apps that act as wireless remote controls or synchronization devices for MRI or X-Ray machines.
- Apps that attach EKG/ECG leads to a mobile platform to collect/analyze/monitor EKG/ECG signals.
- Apps that generate sine signals from 125Hz to 8kHz (eight steps) to check the user's hearing.
- Apps that use the mobile platform with or without a sound transducer (microphone) to act as an electronic stethoscope to amplify heart, lung, blood vessel, enteral, and other body sounds.
- Apps that use the built-in accelerometer or other similar sensors in a mobile platform to monitor the user's movement to determine conditions such as sleep apnea, sleep phase, fall detection, or detect motion related to other conditions or diseases or to measure heart rate.
- Apps that use the light source from a mobile platform to cure and treat specific conditions, such as acne.
- Apps that use a mobile platform to record response time and accuracy of patients completing a cognitive task and/or automatically score or interpret cognitive testing results.
In addition, FDA also specifically noted that drug dose calculators have been previously classified by the Agency (21 C.F.R. 868.1890) and encouraged manufacturers of apps that perform this function to contact the Agency to discuss regulatory requirements. FDA explains that an example of a type of mobile medical app that would be subject to regulation includes apps that "allow the user to input patient-specific information and – using formulae or processing algorithms – output a patient specific results, diagnosis, or treatment recommendation to be used in clinical practice or to assist in making clinical decisions." Examples of these types of apps include those that calculate the amount of chemotherapy needed based on the patient's Body Surface Area; determine the maximum dosage of local anesthesia based on a patient's weight and age; or calculate Osteoporosis Risk Assessment by Composite Linear Estimate (ORACLE score). Other examples of such apps are included in an appendix to FDA's draft guidance.
FDA also outlined several categories of apps that would be definitively excluded from the "mobile medical apps" the Agency plans to regulate, such as medical reference materials (e.g., textbooks) that do not include or use patient-specific information; general health and wellness apps (e.g., calorie counters) that relate to a healthy lifestyle and/or general wellness; automation of general office operations such as billing, inventory, appointments, and insurance transactions; generic aids without a specific medical indication (e.g., note-taking, audio recording); and mobile apps that perform the functionality of an electronic health record system or personal health record system. FDA also notes that the guidance does not address the classification or submission requirements applicable to clinical decision support software.
Regulatory classification of mobile medical apps
Rather than issuing new regulations classifying mobile medical apps, the draft guidance explains that most regulated apps will either fall within an existing device classification or, for those that are accessories to existing devices, would take on the classification of the "parent" medical device. This approach for accessories is consistent with how FDA has handled accessory devices in the past in other contexts. However, FDA also notes that applying the same regulatory requirements to accessory mobile medical apps as to the parent device may not be appropriate in all situations because the accessory app may have significantly more or less risk than the parent device. As an example, FDA cites an app that takes class I device information, combines demographic or other patient-specific information, and results in identification of a highly acute patient condition. Such a use, in the Agency's view, could present significantly greater risk than the class I medical device itself. The Agency is seeking comments on the proposed approach to regulation of such accessory apps.
Although not extensively addressed in the guidance, over the past several years FDA has already cleared, via the 510(k) process, several mobile medical apps. Examples include diabetes management apps that pair with blood glucose monitors, an app that facilitates remote monitoring of near real-time waveforms and other physiologic data from a variety of patient monitoring devices, an app that allows viewing of medical imaging for diagnostic purposes, and an app designed to facilitate remote obstetrical (fetal heart tracings and maternal contractions) monitoring, as well as several apps that pair with devices (e.g., ECG event recorders and ultrasound imaging systems) connected to the mobile platform. Thus, there is already some experience within the Agency regarding review of such technology.
Entities subject to regulation
With respect to distributors of mobile medical apps (e.g., app stores), FDA commented that the Agency expects such distributors to cooperate with manufacturers in conducting any corrections or removals (i.e., recalls) that may be necessary. However, FDA specifically excluded from the definition of "mobile medical app manufacturer" proposed in the guidance any entities that "exclusively distribute mobile medical apps, without engaging in manufacturing functions," such as owners and operators of the iTunes store, Blackberry App World and Android market. Because it is the manufacturer who is largely responsible for compliance with FDA regulations, this clarification is particularly important for those entities involved only in the selling or distribution of apps. Software developers who are "only responsible for performing design and development activities to transform the author's specifications into a mobile medical app" also are not considered manufacturers. By contrast, FDA specifically included within the proposed scope of "mobile medical app manufacturer" anyone who provides mobile medical app functionality through a "web service" or "web support" even if the medical functionality is not included in the local version of the app.
Additional forthcoming FDA guidance on HIT and decision support software
The draft guidance explicitly notes that products performing the function of an electronic health record (EHR) or personal health record (PHR) are excluded from the set of apps over which FDA plans to exercise regulatory oversight at this time. Similarly, the guidance states that it is not intended to address classification or submission requirements for clinical decision support software. In February of 2010, FDA indicated that it viewed all Health Information Technology (HIT) products as within its jurisdiction and was considering whether and to what extent regulation was appropriate. Recent discussions with FDA personnel indicate that a future guidance addressing HIT, potentially including both EHR/PHR and clinical decision support software, is still being developed pending completion of an Institute of Medicine study regarding the affect of HIT products on patient safety. That study report is reported to be expected in January of 2012.
The draft guidance summarizes FDA's current thinking on its approach to regulation of mobile medical apps. Although some of the details of FDA's regulatory approach have yet to be finalized, the guidance also serves as a means of notifying creators and manufacturers that such products are, in FDA's view, subject to regulation.
Because the Agency is not, at this time, proposing new regulatory classifications specific to mobile apps, the information in the draft guidance may leave some manufacturers with a lack of clarity about the appropriate regulatory requirements for their specific apps. For example, although the guidance provides two specific categories of products that the Agency plans to target (accessories to existing devices and apps that transform a mobile platform into a medical device), the guidance also includes extensive discussion of apps providing algorithms that allow the user to generate patient-specific results, diagnoses, or treatment recommendations. It is unclear from the guidance itself whether the Agency views all such algorithms as regulated or only those, for example, that use data derived from medical devices as part of the algorithm. Similarly, FDA is still in the process of determining whether all mobile medical apps that are accessories to existing medical device should be classified according to the "parent" medical device or be such to more or less regulatory oversight depending on the specific risk associated with the app. These issues may be further clarified in the Agency's final version of the guidance, which will not be issued until after the comment period.
FDA is seeking comments on the draft guidance. Comments must be submitted by 29 October 2011.