FDA has issued a draft guidance for the development and implementation of mobile applications for smart technology devices. The guidance is intended to inform manufacturers, distributors, and other entities about how FDA intends to apply its regulatory authorities to select software applications intended for use on these mobile platforms. The guidance was issued on July 21.

“Given the rapid expansion and broad applicability of mobile apps, FDA is issuing this draft guidance document to clarify the types of mobile apps to which the FDA intends to apply its authority” the agency says. “At this time, FDA intends to apply its regulatory requirements solely to a subset of mobile apps that it is calling mobile medical applications or "mobile medical apps."

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word "should" in agency guidances means that something is suggested or recommended, but not required.

“A growing number of software applications are being developed for use on mobile platforms, which include smart phones, tablet computers, and personal digital assistants. As these mobile platforms become more user-friendly, computationally powerful, and readily available, innovators have begun to develop mobile apps of increasing complexity to leverage the portability mobile platforms can offer,” the guidance states. “Some of these new mobile apps are specifically targeted to assisting individuals in their own health and wellness management. Other mobile apps are targeted to healthcare providers as tools to improve and facilitate the delivery of patient care.”

The guidance notes that “as is the case with traditional medical devices, mobile medical apps can pose potential risks to public health. Moreover, mobile medical apps may pose additional or different risks due to the unique characteristics of the platform.” It provides as an example the interpretation of radiological images, noting that on a mobile device, these images could be adversely affected by the smaller screen size, lower contrast ratio, and uncontrolled ambient light of the mobile platform. FDA intends to take these limitations into account in assessing the appropriate regulatory oversight for these products.

This guidance clarifies and outlines the FDA’s current thinking. The agency will continue to evaluate the potential impact these technologies might have on improving health care, reducing potential medical mistakes, and protecting patients.

Anyone can submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to FDA. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.