2015 has been a busy year for the Food and Drug Administration (FDA). In January, the FDA issued guidance documents addressing wellness applications[1] as well as accessories to medical devices and it looks like the administration is continuing the trend into February with a finalized regulatory approach to Medical Device Data Systems (MDDS)[2]. All three of these documents seemed to trace a common line of promoting health information technology (HealthIT) innovation and demonstrate the prevalence the field has had into the FDA’s thinking. Before addressing the applicability to HealthIT, we briefly examine the impact the current guidance has on MDDS regulation.
Until February 9, 2015, MDDS or devices, including software applications, that transfer, store, convert and display medical device data required compliance with regulatory controls put in place by the Food and Drug Administration (FDA). The FDA regulated such functionality when used to cure, mitigate, prevent, treat or diagnose a disease under the Food, Drug & Cosmetic Act. For years, proprietors of devices that had MDDS functionality had to register with the FDA and meet regulatory controls. As FDA gained comfort with MDDS devices, however, it has lowered the regulatory bar such devices are subject to. In 2011, the FDA lowered the regulatory classification of MDDS from Class III to Class I and in June of 2014, the agency proposed to completely deregulate MDDS. When the FDA finalized the June 2014 guidance on February 9, 2015, MDDS was deregulated and the FDA will not enforce compliance with regulatory controls for devices meeting the MDDS definition. It is worth noting that devices which exceed the definition of MDDS by engaging in active patient monitoring or complex transformation of data may still be subject to regulation. Nevertheless, if a manufacture tailors a device to remain within the confines of the definition of MDDS, it will now be able to operate without complying with potentially burdensome registration and other regulatory controls. The FDA has also decided to deregulate medical image storage devices (i.e., devices that provide electronic storage/retrieval functions for medical images) and medical image communications devices (i.e., devices that provides electronic transfer of medical image data between medical devices) because the FDA believes that such devices, like MDDS, pose a low risk to the public.
The implications of the deregulation of MDDS and the related image storage and transmission technologies described above are wide reaching. At a policy level, the deregulatory guidance emphasizes the FDA’s commitment to a risk-based framework for HealthIT that avoids regulatory duplication and avoids overregulation of low risk HealthIT. This suggests that FDA will only target its enforcement authority at truly high risk technologies that pose a sufficient risk to patients to warrant active regulation.
Developers of HealthIT software, including mobile medical applications, should certainly evaluate whether the deregulatory guidance has an immediate impact on the regulatory classification of their products, but also look at the long term implications of the HealthIT regulatory sphere. HealthIT manufacturers should also examine how the deregulation of MDDS relates to the other two recent FDA guidance documents re accessories and wellness applications.
[1] “FDA Issues Guidance for Low-Risk General Wellness Products,” Sheppard Mullin Healthcare Blog, Jan. 23, 2014
[2] Food and Drug Administration. “Medical Device Data System, Medical Image Storage Devices, and Medical Image Communications Devices – Guidance for Industry and Food and Drug Administration Staff.” February 9, 2015.
