The U.S. Food and Drug Administration has issued final guidance documents that take a noticeably lighter regulatory hand when it comes to medical device data systems and mobile applications.
MDDS is hardware or software that transfers, stores, converts formats, and displays medical device data from a variety of other devices including glucose meters, blood pressure cuffs, and weight scales. However, in guidance published today in the Federal Register, FDA states that it does not intend to enforce compliance with the regulatory requirements that apply to MDDS, including registration and listing, premarket review, postmarket reporting, and quality system regulation for manufacturers of these types of devices.
The MDDS guidance confirms our intention to not enforce compliance with applicable regulations for technologies that receive, transmit, store, or display data from medical devices, the FDA's Bakul Patel and Jeffrey Shuren, M.D., said in a jointly credited blog posting. We hope that finalization of this policy will create an impetus for the development of new technologies to better use and display this data. We also updated the Mobile Medical Apps guidance to be consistent with the MDDS final guidance.
In the MDDS guidance, the agency said that since down-classifying MDDS technology in 2011 to Class I (low-risk) from Class III (high-risk), it has gained additional experience with these types of technologies, and has determined that these devices pose a low risk to the public. Therefore, the FDA does not intend to enforce compliance with the regulatory controls that apply to MDDS devices, as well as medical image storage devices and and medical image communications devices.
The guidance is careful to say, however, that MDDS technology does not modify the data, and does not control the functions or parameters of any connected medical device. An MDDS does not include devices intended for active patient monitoring such as a monitor that is intended to detect life-threatening arrhythmias such as ventricular fibrillation, or a device used to actively monitor diabetes for time-sensitive intervention.
In the mobile apps guidance, the agency summarizes its philosophy: "FDAs oversight approach to mobile apps is focused on their functionality, just as we focus on the functionality of conventional devices. Our oversight is not determined by the platform. Under this guidance, FDA would not regulate the sale or general/conventional consumer use of smartphones or tablets. FDAs oversight applies to mobile apps performing medical device functions, such as when a mobile medical app transforms a mobile platform into a medical device. However, as previously noted, we intend to apply this oversight authority only to those mobile apps whose functionality could pose a risk to a patients safety if the mobile app were to not function as intended."
Examples of such apps the agency still intends to regulate include mobile apps that transform a mobile platform into a regulated medical device and therefore are mobile medical apps; mobile apps that connect to an existing device type for purposes of controlling its operation, function, or energy source and therefore are mobile medical apps; and mobile apps that are used in active patient monitoring or analyzing patient-specific medical device data from a connected device and therefore are mobile medical apps.
FDA intends to exercise enforcement discretion, meaning it intends to take a largely hands-off approach, for mobile apps that:
*Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions;
*Provide patients with simple tools to organize and track their health information;
*Provide easy access to information related to patients health conditions or treatments;
*Help patients document, show, or communicate potential medical conditions to health care providers;
*Automate simple tasks for health care providers;
*Enable patients or providers to interact with Personal Health Record (PHR) or Electronic Health Record (EHR) systems; or
*Intend to transfer, store, convert format, and display medical device data in its original format from a medical device.
The latest guidance joins recently issued FDA policies on low-risk products that promote general wellness and draft guidance on medical device accessories. "Through such smart regulation we can better facilitate innovation and at the same time protect patients," Patel and Shuren said.
According to Bradley Merrill Thompson, an attorney at Washington, D.C.-based law firm Epstein Becker Green who counsels medical device companies on regulatory issues, the FDA is sticking to its word by working to down classify or altogether exempt low-risk software-based technologies. In June 2014, FDA issued draft guidance explaining that its regulatory oversight of health information technology products is now focused on devices that pose higher risk to patients than MDDS.
This type of software used to be regulated as an accessory, so if the software was used, for example, to transfer data out of the blood glucose meter, it was class II. Then, in 2011, FDA put such software uniformly in class I regardless of the medical device it accessorized, Thompson tells Health Data Management. That was a huge step, because some of the software connected with class III devices.
Now FDA has exempted the software from all FDA regulation, and indeed swept in image management software, he adds. The implications are profound, both for MDDS type software, but also for what it suggests about the future for health information technology generally. FDA is quite earnestly working to ensure that it uses the lightest regulatory touch appropriate for software. It's exciting, because it means that innovation in this space can truly flourish.
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