FDA Mobile App Enforcement Action Begins

May 28, 2013 Analyst: Dale Cooke

Regulatory Alert

EXECUTIVE SUMMARY
The Food & Drug Administrations (FDA) Center for Devices and Radiological Health (CDRH) has issued an It Has Come to Our Attention Letter to Biosense Technologies, which is the maker of a mobile app that FDA asserts is a medical device that has not received appropriate review.1 This action is following through on the position CDRH previously provided via guidance in July 2011 to regulate certain mobile applications (apps) as medical devices. The facts of this case and its timing make it particularly important for companies that are considering the development of a mobile app that might be classified as a medical device or who currently have an app in market. This case also makes clear the need for class determination of a medical device and working with app development partners who understand medical devices. Digitas Health recommends companies take the following actions: 1. Follow the developments of this enforcement action. The app makers response and subsequent action (or inaction) by the FDA will set precedent for how CDRH will be exercising its regulatory authority in the burgeoning category. 2. For mobile apps that DO fall under the definition of a mobile medical app, determine whether there is a pre-existing device that is comparable to the mobile apps function (e.g., blood glucose test systems) for which FDA has already released regulatory guidance. If that exists, then evaluate your mobile app for compliance with that guidance, and reach out to the FDA to begin the registration process. 3. Consider filing a 513(g) Request for Designation with CDRH to ask FDA to determine the class and consequently the regulatory restrictions that apply to an app.

BACKGROUND
On July 21, 2011, FDAs Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research issued a draft guidance entitled Mobile Medical Applications.2 This guidance is intended to clarify the types of mobile apps to which the FDA intends to apply its authority.3 FDA is currently in the process of finalizing this guidance and has publically declared that it will issue a final version of this guidance in the coming weeks.4 In its draft version of the guidance, FDA set out to establish the subset of mobile apps that it is calling mobile medical applications or mobile medical apps.5 The FDA defines the subset of mobile apps that it will regulate a few pages later in the guidance: When the intended use of a mobile app is 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, the mobile app is a device.6

FDA provided examples of the types of apps it intends to regulate. Of these, the most relevant to this specific enforcement action is: Mobile apps that transform 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 a mobile app that uses a mobile platform for medical device functions, such as attachment of a transducer to a mobile platform to function as a stethoscope, attachment of a blood glucose strip reader to a mobile platform to function as a glucose meter.7 Biosense Technologies markets the uChek system, which consists of a smartphone app ("The uChek app") and a peripheral kit ("The uChek kit"). (emphasis in original)8 It makes use of the iPhone's camera to automatically read commercially available urine dipsticks, using an ingeniously designed peripheral called the "Cuboid" and color mat. The test results may be stored on the phone, analyzed for trends, or emailed. (emphasis in original)9 A video demonstrating the use of the app is available on Biosense Technologies website at https://sites.google.com/site/ucheksystem/how-it-works. Medical devices fall into one of three classes (Class I, II, and III). The specific class a device is in depends on its intended use and the risk associated with that use. Class I devices have the lowest risk and correspondingly the least requirements (called general controls), whereas class III devices have the highest risk and the most significant restrictions, including premarket approval. Once a developer determines that an app is a regulated device, the next step is determining the class of the device to uncover what specific requirements apply. As a rule of thumb, any mobile app that replicates the functionality of a medical device that is not a mobile app will have to abide by the same criteria as the nonmobile app version of the device. For example, a mobile app that analyzes blood glucose readings to help manage diabetes has been classified as part of a Glucose Test System under 21 CFR 862.1345.10

RELEVANT FACTS
According to CDRHs letter to Biosense, the uChek system qualifies as a regulated medical device that requires clearance prior to being marketed.11 On its website, Biosense claims that it has registered the uChek system as a medical device under Product Code KQO. KQO is the product code for automated urinalysis systems, which are Class I medical devices.12 Class I medical devices do not generally require premarket notification via a 510(k) filing. In essence, this enforcement action represents a disagreement about the appropriate classification for a mobile medical app. Is the uChek system a Class I or a Class II device, and does it require premarket notification to CDRH before being marketed? FDA has asked Biosense to provide the the basis for th[e] determination that it is not required to obtain FDA clearance for the uChek Urine analyzer within 30 days of receiving the letter.13

IMPLICATIONS
Many in industry have believed that FDA was holding off on exercising its enforcement authority regarding mobile apps until the final guidance was issued. This action clearly indicates that they are not waiting to review apps that they find to be violative of the current guidance. Companies that are currently developing mobile apps, as well as those with apps in market, should revisit the FDA guidance and check whether their apps fall under the categories set out by FDA as subject to regulatory oversight.
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The developments in this enforcement action will set precedent that industry should assume will inform future actions by CDRH in this burgeoning category. Many questions remain to be answered. How will FDA exercise its enforcement authority when it finds an app out of compliance? If FDA is not satisfied with the response from Biosense, will it request that Apple remove the app from the iTunes Store? If an app that requires premarket submission is marketed without appropriate filing, what will FDA do about the apps that have already been downloaded? Will users suddenly see the app removed from their iPhones? Will any notification be provided?

RECOMMENDATIONS
1. Follow the developments of this enforcement action. The app makers response and subsequent action (or inaction) by the FDA will set precedent for how CDRH will be exercising its regulatory authority in the burgeoning category. 2. For mobile apps that DO fall under the definition of a mobile medical app, determine whether there is a pre-existing device that is comparable to the mobile apps function (e.g., blood glucose test systems) for which FDA has already released regulatory guidance. If that exists, then evaluate your mobile app for compliance with that guidance, and reach out to the FDA to begin the registration process. 3. Consider filing a 513(g) Request for Designation with CDRH to ask FDA to determine the class and consequently the regulatory restrictions that apply to an app.

Document Number: GEN1300289, last accessed from http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm353513.htm on May 28, 2013. Hereinafter Biosense Letter. 2 Draft Guidance for Industry Mobile Medical Applications, last accessed from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm263280.htm on May 28, 2013. Hereinafter, Mobile App Guidance. For a more extended discussion of the draft guidance, see Digitas Health Regulatory Alert: FDA Draft Guidance on Medical Apps Released, published August 4, 2011. Last accessed May 28, 2013 from http://www.scribd.com/doc/61645605/Regulatory-Alert-Medical-Apps-Guidance-Digitas-Health-August-2011 3 Mobile App Guidance, page 4. 4 Foreman, Christy, Keeping up with Mobile App Innovations, blog entry on FDA Voices, March 21, 2013. Last accessed from http://blogs.fda.gov/fdavoice/index.php/2013/03/keeping-up-with-mobile-appinnovations/ on May 23, 2013. 5 Mobile App Guidance, page 4. 6 Mobile App Guidance, page 8. 7 Mobile App Guidance, page 14. 8 Description of uChek from Biosense Technologies website at https://sites.google.com/site/ucheksystem/faqs. 9 https://sites.google.com/site/ucheksystem/home 10 Mobile App Guidance, page 15. 11 Since your app allows a mobile phone to analyze the dipsticks, the phone and device as a whole functions as an automated strip reader. When these dipsticks are read by an automated strip reader, the dipsticks require new clearance as part of the test system. Therefore, any company intending to promote their device for use in analyzing, reading, and/or interpreting these dipsticks need to obtain clearance for the entire urinalysis test system (i.e., the strip reader and the test strips, as used together). Biosense Letter 12 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm?db=PCD&id=KQO 13 Biosense Letter

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Regulatory Alert: Mobile App Enforcement

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