FDA Details Oversight of Medical Applications On Smart Phones and Tablets

A new Food and Drug Administration (FDA) final guidance for manufacturers and developers of medical applications used on mobile platforms specifies that the agency will focus its oversight authority on the functionality of the software applications as opposed to the devices themselves. The FDA will exercise enforcement discretion when it comes to mobile medical applications and focus on those applications that pose a greater risk to patients if they don’t work as intended. FDA cites as an example, “The interpretation of radiological images on a mobile device could be adversely affected by the smaller screen size, lower contrast ratio, and uncontrolled ambient light of the mobile platform.” While the guidance document is interesting to read, it is applicable only to those companies or individuals that actually develop these applications and would likely result in specific labeling and marketing activities. However, if a hospital or health system intends to create a mobile application customized for its own patients or providers, it should read the final guidance. Takeaway: Mobile medical applications are becoming more integrated in the treatment and education of patients, and government oversight is inevitable. Compliance officers should be aware of any government regulations in this area and make determinations […]