Update Nov Dec 2013 - (Page 22)

Enforcement specific information, the use of medical information (e.g. practice guidelines) and a recommendation for diagnosis or treatment. The Guidance does not explicitly use the terms "recommendation for diagnosis or treatment" but the FDA says that the apps will use "patient specific information", use information routinely used in clinical practice (e.g., practice guidelines), in order to "facilitate a user's assessment of a specific patient." These elements are indicative of CDS software.5 * Mobile apps that help patients document, show or communicate to providers potential medical conditions. For example, an app that uses the smartphone built-in camera to take a picture of patient's skin lesions or wounds to supplement or augment what would otherwise be a verbal description in a consultation between healthcare providers and patients. This is quite different from the controversial case of melanoma apps touted as being capable of detecting melanoma. The Final Guidance focuses on the simple functionality of a smartphone camera (like the simple ability to take a picture of a mole). FDA will exercise enforcement discretion for an app that is used to take a picture of a mole, and share it with a doctor for their consultation. * Mobile apps that perform simple calculations taught in medical schools, and routinely used in clinical practice. These are apps that are intended to provide a 22 Update November/December 2013 convenient way for clinicians to perform various simple medical calculations and are routinely used in clinical practice. Examples include medical calculators of Body Mass Index (BMI), APGAR score, etc. The reference to calculations that are "routinely used in clinical practice" indicates that FDA views as low risk those mobile apps using widely accepted clinical content vetted by the medical community. * Mobile apps that enable individuals to interact with PHR systems or EHR systems. These are apps that provide patients and providers with mobile access to health record systems or enable them to gain electronic access, view, or download health information stored within a PHR system or EHR system. These mobile apps are generally meant to facilitate general patient health information management and health record safe-keeping. Although FDA will not actively regulate these types of apps, developers of mobile apps should keep in mind the agency's recommendation that app manufacturers have in place a Quality System. FDA's Oversight of Mobile Medical Apps is Based on Functionality Regardless of the Shape, Size or Platform FDA intends to apply its regulatory oversight only to mobile medical apps. Mobile medical apps are those mobile apps that meet the statutory definition of a medical device and either are intended (1) to be used as an accessory to a regulated medical device, or (2) to transform a mobile platform into a medical device. FDA will regulate these apps because their functionality could pose a risk to a patient's safety if they fail to function as intended. This is consistent with FDA's traditional approach to oversee the medical device functionality of a product and the risks it poses to patients "regardless of the shape, size or the platform." Mobile apps that use attachments, display screens, sensors or other such similar components to transform a mobile platform into a regulated medical device are required to comply with the device classification associated with the transformed platform. For example, a mobile app that uses a mobile platform for medical device functions, such as attachment of a blood glucose strip reader to a mobile platform to function as a glucose meter. Examples of mobile medical apps regulated by FDA include: Mobile apps that are an extension of one or more medical devices by connecting to such device(s) for purposes of controlling the device(s) or displaying, storing, analyzing, or transmitting patient-specific medical device data, including remote display of data for active patient monitoring. Mobile apps that control medical devices. For example, apps that control the inflation and deflation of a blood pressure cuff through a mobile platform and mobile apps that control the delivery of insulin on an insulin pump by transmitting control signals to the pumps from the mobile platform. These types of apps are considered accessories of the medical device to which they connect because they extend the intended use and functionality of the connected medical device. Mobile apps that transform the mobile platform into regulated medical device by using attachments, display screens, or sensors. Mobile apps that perform patient-specific analysis and provide patient-specific diagnosis, or treatment recommendations. For example, apps that create a dosage www.fdli.org http://www.fdli.org

Table of Contents for the Digital Edition of Update Nov Dec 2013

Update Nov Dec 2013