The recent release of two guidance documents addressing current FDA enforcement policies for medical devices that are Medical Device Data Systems (MDDS) and mobile applications (mobile apps), provide further evidence that when it comes to health IT products, FDA’s policy aims to keep unnecessary FDA regulation from impeding the progress of new technologies that offer important benefits in the delivery of health care services and in supporting individual health needs.
The agency justified its MDDS policy based on the low risk to patients MDDS products present, as well as the important role these devices can play in the digital sphere of healthcare. This most recent guidance provides further evidence of FDA’s readiness to exercise enforcement discretion to avoid the imposition of unnecessary regulatory requirements on MDDS products. In issuing the new guidance, FDA emphasized that MDDS products pose low risks to patients and have the potential to play an important role in the digital sphere of healthcare. The new guidance is consistent with FDA’s decision in 2011 to reclassify MDDS from class III (high risk) to class I (low risk) and with similar policy decisions loosening oversight on low risk devices, including the August 2014 draft guidance exempting certain class I and class II devices from premarket notification requirements.
Concurrently, FDA updated its mobile applications guidance to be consistent with its current position regarding MDDS. FDA’s updated Mobile Medical Applications Guidance, originally issued in June 2013, explains FDA oversight of mobile apps is risk-based and limited to those apps that, depending on functionality, could cause harm to patients if they failed to work properly.