On January 26, 2016, the Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance document,Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices (“Draft Guidance”). The Draft Guidance describes design considerations and premarket submission content for medical devices that share data and information with other devices and systems.
The Draft Guidance comes as one more step in the Agency’s effort to address increased connectivity between the tools used in today’s healthcare environment. While recognizing that interconnectivity of various products and systems has the potential to increase effective patient care, the Draft Guidance cautions that there are certain safety considerations that should be addressed to ensure the safe and effective use of connected medical devices and the overall device system. This Draft Guidance is the most recent in a line of guidance documents addressing similar concerns regarding wireless connectivity in medical devices1 and cybersecurity in both the premarket2 and postmarket settings.3 This guidance explicitly addresses the transmission and reception of data through both wired and wireless connections, and the transfer or exchange of information between medical or non-medical technology. While in many ways the Draft Guidance reflects current FDA practice in terms of requests for information for interoperable medical device, the document also proposes considerations that potentially signal a much broader way of thinking about these devices and the context in which they are used.
The Draft Guidance defines, “interoperability” as the “ability of two or more products, technologies or systems to exchange information and to use the information that has been exchanged” where “exchange of information” includes transmission and/or reception through either wired or wireless connections. These connections may present in various forms such as the display, storage, interpretation and analysis or control of another product. The Agency notes that interoperability may be used in a range of activities from very simple, unidirectional, transmission of data to complex interactions including control of one device by another.
Design and Testing Considerations
The agency stresses the need to establish and implement functional, performance and interface requirements for the device. In addition, the Draft Guidance notes the importance of designing testing plans that account for the intended use of the product and the risks associated with that use.
With respect to the design of the device, the Agency encourages developers to consider the following:
- Device design. Manufactures should consider in the device design the level of interoperability required for the device to meet its intended use, including the types of devices that it is intended to connect with, the type of data that will be exchange, method of the data transmission, the necessary timeliness and reliability of the information transfer.
- Anticipated users. Design considerations should account for the different types of users (e.g., physicians, IT professionals) who will interact with the system and who may need different information. Companies may wish to consider developing different instructions for different users.
- Security considerations. An electronic data interface may impact the security and risk management considerations for the products and systems with which it interacts. Therefore, manufacturers should ensure there are appropriate security features included in the design of the device, that the interface does not impact the safety or essential performance of the device, and that the device can appropriately handle data that is corrupted or otherwise outside of the parameters.
- Risk management. The draft guidance recommends that manufacturers perform a risk analysis that explicitly addresses interoperability, reasonably foreseeable misuse, and other reasonably foreseeable situations that could present risks. The Agency acknowledges that a manufacturer cannot be responsible for all possible situations of misuse beyond its intended uses.
In addition, FDA recommends conformance to any FDA recognized consensus standards that may be applicable to the individual product.
With respect to verification and validation, the Draft Guidance notes that interoperable medical devices must be evaluated to demonstrate that the interactions with other products perform as intended. This may include testing with specific products, or if the device is intended to interface with may devices, testing with representative products. Such tests should evaluate scenarios such as whether corrupt data can be detected and managed, whether the device can safely operate even when incorrect parameters are sent or received, the security of access by only authorized users, and whether the user interface of the device is sufficient to allow for correct use. Notably, FDA indicates that where a medical device is intended to be part of a larger system, the manufacturer should conduct testing to assure that the device performs appropriately when “assembled, installed, and maintained according to its instructions.”
Content of Premarket Submissions
FDA acknowledges in the Draft Guidance that certain interoperable medical devices do not require the submission of premarket notifications. However, for those devices which do require premarket submissions, the agency recommends submission of the following information:
- Discussion of electronic data interfaces, including the purposes of the interface and the mode of data transmission/receipt/exchange
- Risk Analysis including evaluation of risks associated with interoperability. Notably, many premarket submissions do not include full device risk analyses. It is unclear whether the Agency is suggesting that a risk analysis should be included for all interoperable devices.
- Verification and validation data regarding electronic data interfaces. The extent of this testing will depend on the purposes of the interface and the risks associated with the device and the interface. This data may include validation of labeling through human factors studies.
- Labeling, meeting the informational requirements discussed below.
One of the more significant aspects of the draft guidance is FDA’s recommendations regarding the inclusion of detailed information in the labeling regarding the interoperability interface. This would include a description of the purpose of the interface, the means of connection, specifications, any applicable contraindications, precautions or warnings, a summary of testing performed to verify interoperability, list of conformance to any standards, recommendations for connections or architectures, settings or configurations as appropriate, and instructions for IT personnel on how to connect/install or disconnect/uninstall the device. While much of this information is fairly intuitive and has previously been requested by FDA in recent submissions, FDA appears to be expanding the type and breadth of information that should be made publicly available in a manufacturer’s labeling.
- The Draft Guidance represents one more step in the Agency’s effort to address risks associated with cybersecurity and connectivity for medical devices. The document places the focus on good design efforts along with robust testing, but makes it clear that manufacturers should think broadly about the contexts in which their products may be used.
- It is unclear whether the Draft Guidance will change the type of information that must be submitted in premarket submissions. For example, it is not yet clear whether FDA will require the inclusion of the full device risk analysis in future 510(k) premarket notifications.
- The recommendations described in the guidance are generally consistent with recent requests we have seen from the Agency in terms of the concerns raised and information required to address those concerns. At the same time, the Draft Guidance appears to expand the concerns from those focused solely on the individual device and its performance to include risks associated with interoperability of entire systems. While a manufacturer can include design elements that enhance the likelihood of successful interoperability with other devices, it is not always possible to anticipate all possible configurations in which a device may operate once purchased. The extent to which the Agency recognizes those limitations is not yet clear in the draft guidance.
Comments are being accepted on the draft guidance through March 26, 2016.