The Journal of mHealth Vol 1 Issue 1 (Feb 2014) - Page 20

FDA Issues Final Guidance on Mobile Medical Apps Continued from page 17 based approach that the agency applies to other medical devices. The agency has stated that it does not regulate the sale or general consumer use of smartphones or tablets nor does it regulate mobile app distributors such as the ‘iTunes App store” or the “Google Play store.” Specific examples of mobile apps that FDA does not consider to be devices and with no regulatory requirements under the current laws administered by FDA include: 1. Mobile apps that are intended to provide access to electronic “copies” (e.g., e-books, audio books) of medical textbooks or other reference “We have worked hard to strike the right materials with generic text search balance, reviewing only the mobile apps capabilities. These are not dethat have the potential to harm conMobile apps vices because these apps are sumers if they do not function intended to be used as refhave the potential properly,” said Shuren. “Our erence materials and are mobile medical app policy proto transform healthcare not intended for use in vides app developers with the the diagnosis of disease by allowing doctors to clarity needed to support the or other conditions, or continued development of diagnose patients with in the cure, mitigation, these important products.” treatment, or prevention potentially life-threatening of disease by facilitating The agency has cleared about conditions outside of a health professional’s as100 mobile medical applicasessment of a specific patraditional healthcare tions over the past decade; about tient, replacing the judgment 40 of those were cleared in the past settings... of clinical personnel, or pertwo years. forming any clinical assessment. Examples include mobile apps that are: The following extracts from the guidance report sets out the type of apps that the FDA consider may meet the definition of medical device but for which FDA intends to exercise enforcement discretion, and those that the department will not consider to be a medical device and therefore outside of the regulatory scope. That is not to say that these applications will not have to meet other regulatory requirements. Examples of mobile apps that are NOT considered medical devices This extract provides a representative list of mobile app functionalities to illustrate the types of mobile apps that could be used in a healthcare environment, in clinical care or patient management, but are not considered medical devices. Because these mobile apps are not considered medical devices, FDA does not regulate them. The FDA understands that there may be other unique and innovative mobile apps that may not be covered in this list that may also constitute healthcare related mobile apps. This list is not exhaustive; it is only intended to provide clarity and assistance in identifying when a mobile app is not considered to be a medical device. 18 February 2014 • • • • • • Medical dictionaries; Electronic copies of medical textbooks or literature articles such as the Physician’s Desk Reference or Diagnostic and Statistical Manual of Mental Disorders (DSM); Library of clinical descriptions for diseases and conditions; Encyclopedia of first-aid or emergency care information; Medical abbreviations and definitions; Translations of medical terms across multiple languages. 2. Mobile apps that are intended for health care providers to use as educational tools for medical training or to reinforce training previously received. These may have more functionality than providing an electronic copy of text (e.g., videos, interactive diagrams), but are not devices because they are intended generally for user education and are not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease by facilitating a health professional’s assessment of a specific patient,