As many of our readers know, the role of the FDA is evolving with respect to mobile medical software and devices. There is no question that the FDA has jurisdiction to regulate medical software, not to mention a responsibility. In this article, we will examine the basics of FDA regulation of medical devices.
Today, the FDA finally released a detailed draft guidance of how it intends to regulate this rapidly exploding sector of mobile medical devices and software.
The regulatory status of medical apps, i.e mobile medical software, has been in limbo for some time now while observers have been watching the FDA for clues as to what role it will play. Clearly, some apps do play a role in guiding physicians in making diagnoses or making treatment decisions. Others simply provide information […]
By: Jonathan Baran With the recent explosion of mobile technology, applications only possible in our imaginations can now be brought to the devices sitting in our pockets. If executed correctly, these apps have the potential to transform clinical practice. Before embarking on a potentially expensive development process, however, it is important to ask some important […]
American Medical News (amednews.com) recently reported on statements made in February by FDA officials regarding regulation of medical software.