Sep 30, 2019
The US Food and Drug Administration has updated and finalized guidance to determine which mobile medical applications fall under medical device oversight requirements based on their functions.
FDA’s final guidance replaces draft guidance issued in 2013, and aligns with requirements in the 21st Century Cures Act of 2016 for determining whether or not a digital health tool or product qualifies as a mobile medical device (and therefore as a medical device). The agency has also published updated guidances on related issues such as off-the-shelf software for medical devices and medical device data systems (MDDS).
The final guidance scope keeps longstanding definitions in place: telehealth products and technologies are considered mobile medical apps if intended for use either as accessories to other regulated medical devices or to transform mobile technology platforms into regulated devices.
Now that FDA guidance on mobile medical apps has been updated according to new legislative requirements, the list of digital health products not considered regulated devices has grown. The agency identifies 21 software functions that fall outside the scope of the final guidance, including:
Again, FDA criteria for which telehealth products fall under agency oversight as medical devices remains consistent in the final guidance:
Highly anticipated draft guidance on mobile medical applications has been published by the FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER).
Targeting specific subsets of mobile medical device applications, the guidance should help answer some longstanding industry questions of how—or whether—US and other regulators would approach such devices. The guidance could furthermore serve as a template for other medical device market regulators determining how to establish requirements for this burgeoning sector of the device industry.
Now that the US Food and Drug Administration’s final guidance on mobile medical apps is finally published, developers and manufacturers should have a much better idea of which products will fall under regulatory oversight in the US and which will not. The guidance divides mobile apps into three broad categories: