Loading
The Food and Drugs Authority (FDA) has recently issued the draft guidance document for mobile medical applications considering the fast expansion and broad applicability of these devices. In 1989, FDA had prepared a general policy. It was withdrawn subsequently due to the growing complexities attached to computer software products as medical devices, and also the impracticalities of making an overarching software policy containing regulatory issues connected to all medical devices. By releasing the draft guidelines, FDA has acknowledged the need to act as regulator in matters of selecting software applications intended for use in mobile applications by manufacturers and distributors of these applications.
Why Regulatory Controls
Mobile applications are software programs that run on smart-phones and other mobile communication devices executed on a server. Development of mobile medical applications has opened flood gates of innovative technology looking for ways to improve health and healthcare. Innovation in software applications have paved the way for sprouting of several computationally powerful and user friendly mobile platforms, viz., smart phones, tablet computers, personal digital assistants, etc. Spurred by the sudden acceptability of these products, more and more complex mobile applications have started entering the market; some targeting individuals in their own health management and some targeting healthcare providers as tools that can improve delivery of patient care.