In an effort to keep pace with its oversight of advanced medical devices and platforms, the U.S. Food and Drug Administration (FDA) has issued a final guidance document detailing its expected approach in reviewing and regulating specific aspects of software functionality found in mobile medical applications.
Importantly, the guidance makes clear that the FDA’s expected focus on device functions will be “independent of the platform on which they might run, are function-specific, and apply across platforms.” Further, the guidance says that the FDA intends to apply its regulatory oversight to “only those software functions that are medical devices and who functionality could pose a risk to a patient’s safety if the device were to not function as intended,” and that it intends to exercise “enforcement discretion” over lower risk functions.
Guidance documents issued by the FDA do not have the force of law, but can provide useful information for device manufacturers seeking to achieve compliance with FDA regulations.
Read the FDA’s Guidance on Device Software Functions and Mobile Medical Applications.
