Are Apps Medical Devices?

In 2013 the FDA released the Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff to clarify the agency’s regulation of mobile medical apps. An important element of this report was the description of mobile medical apps that meet the definition of a medical device according to section 201(h) of the Federal Food, Drug & Cosmetic (FD&C) Act. According to the FDA, a  mobile app is a medical device if its intended use is 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; this also includes apps that are marketed, labeled, distributed, and promoted for use by clinicians in examining patients.6 If a mobile app does meet this definition, the app developers must determine the device to be Class I, II or III based on their risks (Class I lowest risk, Class III highest) and register with the FDA a Premarket Notification (PNM or 510k clearance) of their intent to market the app as a medical device at least 90 days in advance of the release of the product.

Issues and Solutions

After the release of these recommendations, Biosense Technologies Private Limited was notified by the FDA that their uChek Urine analyzer, which integrates an app with a portable diagnostic station and non-proprietary reagent strips for an automated reading, met the definition of a medical device but was not cleared by the agency. The uChek Urine analyzer was listed on the FDA website earlier in 2013 as a Class 1 medical device but devices measuring blood or glucose in the urine (like the uChek device) require Class 2 device designation. The company eventually decided to forgo seeking FDA clearance for this app and instead focus on a new system that will be submitted for clearance.7,8

Other companies are taking a different approach by pre-selling their mobile medical devices under the FDA’s Investigational Device Exemption, where data on the safety and efficacy of the devices will be included in the application for 510(k) medical device clearance.  One of these is Cue, a device that utilizes proprietary cartridges to assess levels of free testosterone, luteinizing hormone, C reactive protein, and vitamin D.  The results are then sent by Bluetooth from the device to the app and recommendations on diet and activity to improve these measurements are given. The device can also detect influenza A; if the flu is detected, the manufacturers urge the patients to seek medical treatment. Cue is available for pre-order and expects to begin shipping in spring 2015.9


Despite the promise of mobile medical apps for monitoring and diagnostics, present research does not support replacing current standards with the apps. Smartphone technology is constantly evolving so it is possible that one day mobile medical apps could be used alongside other diagnostic tools for a more thorough patient assessment.


1.      research2guidance. mHealth App Developer Economics 2014: The state of the art of mHealth publishing. . Accessed June 24, 2014.

2.      Sparks D. Apple highlights new Mayo Clinic app during worldwide developers keynote. Mayo Clinic News Network. June 2, 2014. Accessed June 24, 2014.

3.      Wolf JA, Moreau JF, Akilov O, et al. Diagnostic inaccuracy of smartphone applications for melanoma detection. JAMA Dermatol. 2013; 149(4): 422-426. doi:10.1001/jamadermatol.2013.2382.

4.      O’Neill S, Brady RR. Colorectal smartphone apps: Opportunities and risks. Colorectal Dis. 2012; 14(9), e530-e534 . doi: 10.1111/j.1463-1318.2012.03088.x.

5.      Wackel P, Beerman L, West L, Arora G. Tachycardia detection using smartphone applications in pediatric patients. J Pediatr. 2014; 164(5), 1133-1135. doi: 10.1016/j.jpeds.2014.01.047.

6.      U.S. Department of Health and Human Services Food and Drug Administration. Mobile medical applications: Guidance for industry and food and drug administration staff. Accessed June 24, 2014.

7.      Woods, JL. Letter to Biosense Technologies Private Limited concerning the uChek Urine Analyzer. Office of In Vitro Diagnostics and Radiological Health Food and Drug Administration. Accessed June 24, 2014.

8.      Gaglani, S. uCheck launches indiegogo campuagn: Interview with CEO Myshkin Ingawale. . Accessed June 24, 2014.

9.      Cue. Accessed June 24, 2014.