FDA Loosens Leash on Device Regulation
In what has been described as a “stark reversal,” the U.S. Food & Drug Administration (FDA) released new draft guidance June 20 concerning regulation of medical device data systems (MDDS), medical image storage devices, and medical image communications devices. The draft guidance serves as notification that the FDA does not intend to enforce regulatory compliance on these devices (in contrast to its prior intent of regulating them as low risk devices). With this reversal, the FDA is also recommending revisions to the Mobile Medical Applications guidance it released last September.
Pharmaceutical marketers involved in developing apps for consumers or healthcare professionals should review and understand this new information as it relates to their projects.
In essence, refreshingly, the draft guidance lifts restrictions and paves the way for more open innovation in the digital health landscape.
The FDA does not plan to enforce regulatory controls over three types of devices (as defined below) because they don’t view these devices as posing a high risk to patients.
- Medical device data systems (MDDS): The agency defines MDSS as hardware or software that “transfer, store, convert formats, and display medical device data.” These would include, for example, software that stores and/or displays a patient’s blood pressure readings for review by a healthcare professional. (This MDSS designation does not include devices that modify data or control the functions or parameters of any connected medical device, nor any devices involved in active patient monitoring.)
- Medical image storage devices: Medical image storage devices are defined as devices that provide electronic storage and retrieval functions for medical images, as defined under 21 CFR 892.2010.
- Medical image communications devices: Medical image communications devices are defined as devices that provide electronic transfer of medical image data between medical devices. This is further defined under 21 CFR 892.2020.
It’s worth noting there are some limitations to the exemption which will require premarket notification submissions, known as 510(k)s. But for most devices that meet the above definitions, the FDA does not intend to enforce compliance with their regulations, including “registration and listing, premarket review, post-market reporting and quality system regulation for manufacturers of these types of devices.”
“The FDA’s ‘does not intend to enforce compliance’ language is reminiscent of ‘exercise enforcement discretion' language used in the September medical mobile apps guidance.”
The “does not intend to enforce compliance” language is reminiscent of language used in the September guidance. There the FDA pointed out there are types of mobile medical apps that may meet the definition of a medical device, but that in some cases, the FDA intended to “exercise enforcement discretion.” In both guidances, the FDA is maintaining it has the power to regulate these types of technologies, but they see them as low-risk.
WHY THE FDA CHANGED THEIR TUNE
The FDA seems to have changed their view based on a variety of factors. In the document’s very first paragraphs, the FDA recognizes the importance of the progression of digital health, its potential for better patient care and improved health outcomes, and the need for open interoperability between the systems that support it.
“ … the FDA recognizes the importance of the progression of digital health, its potential for better patient care and improved health outcomes, and the need for open interoperability between the systems that support it.”
In an uncharacteristic mea culpa, the agency admits it is changing its view and downgrading its interest in regulating these technologies because they have gained a better understanding of them. The FDA makes it clear that it does not intend to enforce compliance due “to the low risk they pose to patients and the importance they play in advancing digital health.”
The timing is worth noting, as both Apple and Google recently announced plans to integrate health data aggregators into their respective platforms. This proposed guidance was released roughly two weeks after Apple’s HealthKit announcement and one week before Google announced Google Fit. Perhaps potential tech and data giants such as Apple and Google have been working closely with the FDA to inform, educate and understand each other’s viewpoints. It’s also likely the FDA has gained a deeper understanding of the issues and nuances of these technologies by reviewing comments submitted by the industry.
In any case, this reversal is a good reminder that the FDA is, first and foremost, looking out for public safety and is not — despite popular opinion — purposefully blocking innovation.
IMPLICATIONS AND RECOMMENDATIONS FOR PHARMA
- Advancing digital health: Those who are advancing digital health technology will find value in this proposed guidance. Rather than providing additional regulation, this draft guidance actually lifts regulations and renders irrelevant some questions, clearing the way for innovation.
- Implications for mobile medical apps: Pharmaceutical companies developing mobile apps for patients and healthcare professionals should understand how this draft guidance affects apps that are in-market or in the planning stages. The latter half of the document outlines the edits FDA is proposing to the 2013 Mobile Medical Applications guidance, updated to reflect new thinking, and includes actual text strikethroughs and deletions/additions of relevant examples. Most important for pharmaceutical marketers to understand is that, as long as a mobile app does not diagnose, treat or is used in connection with active patient monitoring, the agency does not intend to enforce compliance. This is consistent with the original mobile medical app draft guidance.
- Open exploration of Apple HealthKit and Google Fit: With this draft guidance, pharma companies who want to leverage the benefits of HealthKit and Fit may now proceed with a better idea of the regulatory landscape.
- Keeping the conversation going: No doubt feedback from the industry — including comments formally submitted in response to past guidances — played a role in the FDA’s increased understanding of this landscape. Concerning mobile, social and other important guidance topics, the industry should feel empowered to continue to voice its opinions. The FDA is, apparently, listening.
- A welcome change of heart: In all draft guidance, the FDA makes it clear that they have the right to change their mind, that these guidance documents describe “the Agency’s current thinking on a topic.” In this case, the easing of restrictions around medical data, image storage and image communications devices is a welcome reprieve from what can feel like a heavy-handed regulatory approach. We applaud the agency’s efforts to provide guidance that protects patient safety while allowing for digital health innovation.
Pharmaceutical marketers and their partners appreciate having clear direction — and, dare we say, leeway — from the FDA. We expect this guidance to further open up stalled or sidelined discussions surrounding mobile health apps. Overall, it provides clarity and reduces confusion, enabling pharmas to bring even more valuable tools and services to their customers.