On September 23, 2013, the U.S. Food and Drug Administration (FDA) issued the long awaited final guidance (Guidance) on mobile medical apps. The FDA reaffirmed that it "intends to exercise enforcement discretion (meaning it will not enforce requirements under the Federal Drug & Cosmetic Act) for the majority of mobile apps as they pose minimal risk to consumers" and instead will "focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended."
There was significant concern from software developers, vendors, and other industry representatives regarding the regulatory position(s) the FDA would take and the resultant impact on the mobile app development market. The Guidance informs stakeholders how the FDA intends to apply (or decline to apply) its regulatory authorities to healthcare oriented mobile apps.
The FDA intends to regulate a subset of apps that it has labeled as "mobile medical apps," which must meet all of the requirements below:
Resources and Supporting Documents