The U.S. Food and Drug Administration (“FDA”) recently issued guidance on an array of medical device-related software and systems. A first guidance for “Data Systems and Imaging Devices” issued on February 9, 2015, and contains nonbinding recommendations for “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.” This first guidance expresses the FDA’s intention to not regulate many of these systems and devices. However, a second guidance issued on the same day for “Mobile Medical Apps” and identifies a subset of mobile device software or “apps” that the FDA does intend to regulate. Both of the guidances are meant to convey the FDA’s “current thinking” on the respective topics and do not operate to bind the FDA or industry.
The first guidance for “Data Systems and Imaging Devices” states that it is in response to growth in “digital health” and in recognition of the need to communicate and display medical data across multiple computing platforms. The guidance further states that the FDA believes that medical device data systems, medical image storage devices, and medical image communications devices pose a low risk and are important in advancing digital health, and that therefore the FDA “does not intend to enforce compliance with the regulatory controls” for these systems and devices.
According to the guidance, systems and devices for which compliance will not be enforced include hardware or software that transfers, stores, retrieves, converts formats, or displays medical device data or images. For such devices and systems, the FDA does not intend to enforce manufacturer compliance with premarket review, postmarket reporting, or quality system regulation. However, this category does not include devices or systems that modify the data, control the functions or parameters of any connected medical device, or are used for active patient monitoring. The guidance provides, as an example of a device that would not be subject to compliance, a data system that is an in vitro device intended for assessing the risk of cardiovascular diseases or for use in diabetes management.
The second guidance for “Mobile Medical Apps” is in response to the proliferation of software or “apps” on mobile devices used for health purposes. The guidance notes that it was issued to let industry know that the FDA intends to enforce compliance for a subset of such mobile apps. That subset includes mobile apps that fall under the definition of a medical device and “whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended.” Therefore, according to the guidance, a mobile app that constitutes a “medical device” but poses a low risk to the public will not be subject to the regulation.
The guidance states that a “mobile medical application” is an app that meets the statutory definition of a “medical device” and that is either a) intended for use as an accessory to a regulated medical device or b) transforms a mobile platform into a regulated medical device. The guidance further notes that consistent with existing criteria, an app will be considered a “medical device” if the intended use is to diagnose, cure, mitigate, treat, or prevent disease or to affect the structure or function of the body.
Some examples of apps that the guidance identifies as being subject to compliance include apps that:
- control inflation and deflation of a blood pressure cuff through a mobile platform;
- control the delivery of insulin on an insulin pump by transmitting control signals to the pumps from the mobile platform;
- use an attachment of a blood glucose strip reader to a mobile platform to function as a glucose meter;
- use an attachment of electrocardiograph (ECG) electrodes to a mobile platform to measure, store, and display ECG signals;
- use a built-in accelerometer on a mobile platform to collect motion information for monitoring sleep apnea;
- use sensors (internal or external) on a mobile platform for creating electronic stethoscope function;
- display radiological images for diagnosis
- use patient-specific parameters and calculate dosage or create a dosage plan for radiation therapy;
- are Computer Aided Detection (CAD) image processing software; or
- are radiation therapy treatment planning software.
The guidance also provides a lengthy discussion of who may be considered a “mobile medical app manufacturer” subject to compliance. This includes software designers and programmers, but it does not include distributors who do not manufacture the apps, such as owners or operators of Google play, iTunes App store, and BlackBerry App World.
This is merely an overview of the recent guidance from the FDA and much more information is available in the respective documents. The complete guidance document for the “Data Systems and Imaging Devices” guidance can be found here, and the complete guidance document for “Mobile Medical Apps” can be found here.
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