The FDA issued its final guidance on the regulation of health apps and other software, bringing a sigh of relief to mHealth app developers all around the world.

The Agency opted for a hands-off approach to most medical device data systems (MDDS), or software that conveys data to and from a medical device.

“This guidance confirms our intention to not enforce regulations for technologies that receive, transmit, store, or display data from medical devices,” the FDA statement reads. “We hope that finalization of this policy will create an impetus for the development of new technologies to better use and display this data.”

In general, the FDA will not regulate apps that don’t pose a real health threat to the user if they malfunction.The Mobile Medical Apps guidance has been updated to be consistent with the MDDS final guidance. In general, the FDA will not regulate apps that don’t pose a real health threat to the user if they malfunction. Also, apps that allow users to document or track basic health metrics, or self-manage a disease or condition without providing specific treatment advice will be left alone.

“This is a very natural extension from the recent FDA guidance on accessories where FDA acknowledges that the risk associated with an accessory is not necessarily the same as the risk of the parent medical device,” according to VentureBeat‘s go-to FDA regulation specialist, attorney Brad Thompson, who works with medical devices makers to navigate the FDA regulatory waters.

This latest guidance comes on the heels of two recently released draft guidances that explain how the Agency intends to regulate low-risk hardware and software products focused on general wellness and medical device accessories. It will take a similar light regulatory approach to these product classes.