By Allyson B. Mullen –
On January 26, FDA issued the draft guidance “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.” A copy of the draft guidance can be found here. The draft guidance addresses design and premarket issues related to the interoperability of devices, which it defines as the “ability of two or more products, technologies or systems to exchange information and to use the information that has been exchanged.” Exchange of information is defined as the “transmission, reception or both, that may be accomplished by means of wired or wireless methods that may exist on a local network, or through the internet.” The guidance indicates that it is addressing more than unidirectional sending of patient data, and includes complex interactions including control of medical devices.
FDA states that in order to ensure the safe performance of the interoperable devices, the manufacturers must establish appropriate functional, performance, and interface requirements. Failure to do so may lead to device malfunction, patient injury, and possibly death according to the draft guidance, which gives as an example the transmission of patient weight in kilograms when the receiving device assumes the weight is in pounds.
The draft guidance includes three major topic areas: (1) design considerations for interoperable devices, including testing and risk management of interoperable devices; (2) content of premarket submissions for interoperable devices; and (3) labeling considerations for interoperable devices.
Design Considerations. The draft guidance provides recommendations to be incorporated during the design and development of interoperable devices, including identifying the purpose of the electronic data interface and anticipated users, performing appropriate risk management and verification and validation testing, and adequately labeling of the device. As part of the risk management activities, the draft guidance suggests that manufacturers consider data security, including cybersecurity of interoperable devices. FDA recently issued a draft guidance on postmarket considerations for device cybersecurity. Our blog post on this draft guidance can be found here.
The draft guidance recommends that manufacturers perform testing that appropriately demonstrates the electronic data interface and exchange interactions perform as intended both on the device itself and when incorporated into the intended interoperable system. It provides several examples of tests to consider.
Content of Premarket Submissions. The draft guidance also provides suggested premarket submission content that is specific to interoperable devices and goes beyond the standard content described in other FDA guidance documents (e.g., the 510(k) RTA Checklist). The recommended content includes specific device description information, including the purpose of the interface and technical details of the data exchange. A risk analysis is also recommended. Risk analyses, although generally prepared during device design and development, are not typically provided in premarket submissions.
The draft guidance also provides specific suggestions for the verification and validation section of premarket submissions. In addition to test results, FDA recommends that manufacturers clearly specify the other devices with which the subject device is intended to be used. If there is a class of devices with which the subject device is intended to be used, the submission should explain why the testing is appropriate for the entire class of devices.
This position is consistent with FDA’s current expectations for devices that are intended to be used together (not specifically interoperable devices). We note that, while FDA leaves open the possibility of testing a device to include an entire class of devices, in our experience, FDA has been unwilling to permit references to a class of products in device labeling and has limited labeling to devices for which data has been provided showing that they work together.
Labeling. Finally, the draft guidance provides a detailed list of suggested labeling content for interoperable devices. The draft guidance appears to focus primarily on ensuring that the user is provided with appropriate information regarding the purpose, use, and limitations of the devices and data exchange interface. The draft guidance recommends that manufacturers perform human factors testing to validate labeling. While not expressly referenced in the premarket submission section of the guidance, it is likely that FDA would expect the results of human factor testing to be included in a premarket submission.
Although the draft guidance is not yet final or legally binding, it is possible that FDA reviewers may be looking at interoperability during their premarket review of device submissions. Accordingly, applicants would be well advised to be prepared to answer questions regarding interoperability of their devices sooner rather than later.