Update Nov Dec 2013 - (Page 21)

Enforcement FDA Will Not Regulate Your Phone or Your Tablet In the Final Guidance, FDA indicates that it will not regulate the sale of general consumer use devices such as smartphones or tablets, nor does it regulate mobile app distributors such as the 'iTunes App store" or the "Google Play store." FDA also clarifies the definition of a "manufacturer." Under the Final Guidance, the term "mobile medical app manufacturer" does not include persons who exclusively distribute mobile medical apps without engaging in manufacturing functions; examples of such distributors may include owners and operators of "Google play," "iTunes App store," and "BlackBerry App World."2 FDA Will Not Regulate Apps that are NOT Medical Devices FDA provided specific examples of mobile apps that FDA does not consider to be medical devices: * Mobile apps intended to provide access to electronic "copies" of medical textbooks such as Physician's Desk Reference; * Mobile apps intended for general patient education. For example, apps that guide patients to ask appropriate questions to their physician relevant to their particular disease or condition; * Mobile apps for general office operations (billing, insurance, or accounting functions). FDA Will Use Enforcement Discretion for Apps That Pose Low Risk to Patients Section V(B) and Appendix B of the Final Guidance are dedicated to apps subject to enforcement discretion. Some of these apps may objectively be classified as medical devices and subject to FDA FDLI regulations. However, through enforcement discretion FDA has chosen not to enforce its regulations when the following apps pose little to no risk to patients: * Mobile apps that provide or facilitate supplemental clinical care, by coaching or prompting, to help patients manage their health in their daily environment: apps that coach patients with conditions such as cardiovascular disease, hypertension, diabetes or obesity, and promote strategies for maintaining a healthy weight, getting optimal nutrition, exercising and staying fit. This category gives clarity on many types of apps used for management of chronic diseases. The Final Guidance recognizes that these types of coaching apps help patients manage their health. FDA, however, did not go so far as to draw the line in the sand between regulated disease intended uses, and non-regulated wellness intended use. This category also includes medication reminders. This is an important clarification because medication reminders are simple and efficient tools that help patients adhere to their treatment regimen. * Mobile apps that provide patients with simple tools to organize and track their health information. These are apps that provide patients with tools to organize and track health information without providing recommendations to alter or change a previously prescribed treatment or therapy. * FDA views these apps as "tools which are not intended to provide specific treatment recommendations and/or are not part of diabetes management referred to in 21 CFR 862.9(c) (5)."3 Patients use these apps to log, track or trend their measurements (drug intake time, blood pressure measurements) "and share this information with their health care provider as part of a disease-management plan." This reference to patients sharing the information with their health care provider and the exclusion of specific treatment recommendations seem to indicate that FDA considers making a specific diagnosis or treatment recommendation higher risk. Apps subject to enforcement discretion can capture and register patient measurements, but in the end, the health care provider is the one making specific diagnosis or treatment recommendations. * Mobile apps that provide easy access to information related to patients' conditions. These apps match patient-specific information (e.g., diagnosis, symptoms) to reference information routinely used in clinical practice (e.g., practice guidelines) to facilitate the assessment of a specific patient. Examples include: apps that use a patient's diagnosis to provide a clinician with best practice treatment guidelines for common illnesses or conditions such as influenza; apps that are drug-drug interaction or drug-allergy look-up tools. * The examples above contain some of the elements of Clinical Decision Support (CDS) software. 4 The specificity of CDS is the use of patient November/December 2013 Update 21

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

Update Nov Dec 2013