FDA Will Focus Enforcement Efforts On Software That Could Risk Patient Safety

In a new guidance on medical software functions, FDA said it will focus its enforcement efforts on a relatively narrow category of software that meets the definition of a medical device and could potentially harm patients if functioning incorrectly. The agency “intends to apply its regulatory oversight to only those software functions that are medical devices and whose functionality could pose a risk to a patient’s safety if the device were to not function as intended,” it wrote in the...