FDA Draft Guidance Could Spur Innovation in Diabetes, Cardio Spaces

By Yarmela Pavlovic and Jennifer A. Henderson

A recent FDA draft guidance titled Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices proposes that the agency refrain from regulating certain low-risk storage and communication systems. Following the tri-agency FDASIA Health IT Report issued in April 2014, which proposes a risk-based framework for health information technology, FDA’s proposed hands-off approach for these systems has signaled a general commitment to implementation of such a framework. In addition to the agency’s involvement in the FDASIA report, FDA’s change of course is driven by a number of other factors, including greater agency experience with these types of technologies, their low-risk nature, public feedback received as part of the FDASIA health IT risk-based framework, and the foundational role that these devices play in the larger health IT ecosystem.

Pointing to these devices as the basis for intercommunication and interoperability among medical devices and between medical devices and other health IT, FDA is predicting that the policy shift will encourage greater innovation in the development of these systems and in advancing digital health. The agency’s proposed regulatory stance would also open the gate for particular innovation and development of such devices for use in cardiovascular disease and diabetes management.

The draft guidance informs manufacturers, distributors, and other entities that the agency does not intend to enforce compliance with applicable regulatory controls for medical device data systems (MDDS), medical image storage devices (MIS), and medical image communications (MIC) devices, all of which are currently regulated as Class I devices. While these devices are already specifically exempt from premarket notification requirements, they remain subject to the remainder of FDA’s general controls, including registration and listing, postmarket reporting, and the quality system regulation (QSR). If finalized in its current form, the draft guidance would result in the agency refraining from enforcement of all regulatory requirements for this subset of hardware and software that transfers, stores, converts, formats, and displays medical device data or medical imaging data.

Although most systems that fall under this guidance are already exempt from premarket notification, by current regulation those that are used in diabetes management or for assessment of cardiovascular disease risk are not exempt. Notably, the draft guidance proposes that the agency would refrain from all enforcement, even for these special categories. In other words, even for an MDDS device that is specifically labeled for use in diabetes management—which, under normal circumstances, would trigger the need for 510(k) clearance—FDA does not intend to require compliance with the premarket notification requirements or any other general medical device controls, including the QSR requirements.

The draft guidance also clarifies that a similar approach would be taken for these devices when provided as mobile medical applications. Specifically, the draft guidance proposes corresponding changes to the final September 2013 guidance on mobile medical apps. The proposed changes largely remove MDDS references, related language about MDDS functionality, and specific examples of such devices, from the group of mobile medical apps subject to active FDA regulation.

For the group of MDDS mobile medical apps subject to enforcement discretion, the draft guidance proposes revisions to the description of mobile applications that provide patients with simple tools to organize and track their health information without providing recommendations. In fact, FDA has already updated the online list of mobile medical apps subject to enforcement discretion to include apps that “allow a user to collect, log, track, and trend data such as blood glucose, blood pressure, heart rate, weight, and other data from a device to eventually share with a healthcare provider or upload it to an online (cloud) database.” Thus, such applications would be subject to enforcement discretion whether or not they meet the definition of an MDDS, MIC, or MIS. These steps represent a significant loosening in FDA’s regulatory policy for simple, patient-focused tools intended to help them track health information related to these conditions.

The proposed policy shift would be a welcome change for many in industry who have either already entered the market with general low-risk storage and communication devices or who have decided to forgo developing such products due to the significant burdens of complying with the QSR. The more significant impact of the proposed regulatory approach, however, would appear to be for developers of such devices intended specifically for the management of cardiovascular disease and diabetes. Such devices would, under existing regulations, exceed the limitations on the exemption and require premarket review.

However, the guardrails of this proposed policy are less clear in terms of where FDA may draw the line and consider an MDDS device intended for diabetes management to have exceeded the agency’s tolerance for exercising enforcement discretion for a product that technically already exceeds the limitations on the exemption. It is not hard to imagine that certain claims or functionalities associated with these types of devices, when intended for these specific uses, may lead FDA to draw a line.

It remains to be seen whether this proposed approach to spur innovation will, in the end, lead to greater innovation and development. The agency’s use of guidance to communicate this policy shift, as opposed to formal comment and rulemaking, technically means that this policy, if finalized in guidance form, is just that, guidance, which is informal, nonbinding, and subject to change at any time. While this policy shift represents an important step by the agency, greater certainty in the form of final regulation would likely prove more helpful to innovation. For example, the agency could alter the classification regulations for these systems to specifically exempt them from premarket notification and all general controls. Such rulemaking would require notice and comment before the agency could reverse the policy.

By comparison, the current proposal will impart some level of uncertainty as companies decide how best to move forward. Companies with existing quality systems in place may find that, for business or other reasons, it makes sense to bring these devices under the quality system despite FDA’s proposed enforcement discretion position. On the other hand, for companies that do not have a quality system in place, they may determine that the risk of proceeding without compliance is worthwhile, even if the agency may, at some point in the future, change its position fairly quickly, necessitating a considerable amount of time and resources to retrospectively bring devices into compliance.

Nonetheless, for devices specifically intended for use in the management of cardiovascular disease or diabetes—conditions that require close and accurate tracking of physiological parameters—design and development of such systems under robust quality management principles, whether per 21 CFR 820 or some other well-established quality management standard, may well be advantageous from a general liability perspective, even if not required under the proposed policy.

Importantly, the draft guidance should not be relied upon until finalized, and in cases where companies have products with an unclear profile, it is advisable to discuss the applicable regulatory requirements with FDA, either informally or formally.

Yarmela Pavlovic is a partner in Hogan Lovells’s Philadelphia office. Her practice focuses primarily on FDA regulation of medical devices.

Jennifer Henderson is a counsel in Hogan Lovells's Washington, DC office. Her practice focuses primarily on medical device issues.

[image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]