“The Food and Drug Administration (FDA) is now proposing guidelines that outline the small number of mobile apps the agency plans to oversee—medical apps that could present a risk to patients if the apps don’t work as intended.” The FDA, the United States Food and Drug Administration, has announced proposed regulations regarding medical apps.
The summary of the guidelines state “At this time, FDA intends to apply its regulatory requirements solely to a subset of mobile apps that the Agency is calling mobile medical applications (mobile medical apps). This draft guidance is not final nor is it in effect at this time.”
The FDA will be accepting comments on the proposed regulations. The agency further advises the public “to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 19, 2011.”