On September 6, 2017, almost two years after first issuing its draft guidance, the FDA issued its final guidance on “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices” (“Guidance”)1. This Guidance is intended to address the tension between interoperability and security of medical devices by identifying specific considerations when developing and designing interoperable medical devices; it also provides specific recommendations regarding the contents of pre-market submissions and device labeling.
The 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.” As noted by Bakul Patel, associate director for digital health in FDA’s Center for Devices and Radiological Health, the Guidance is yet another step in the agency’s pursuit of safety for interoperable medical devices. While interoperability offers tremendous benefits for patient care, failure to adhere to performance requirements may lead to “the exchange of inaccurate, untimely, or misleading information. It may also lead to device malfunction, including the failure to operate, and could lead to patient injury and even death.”2
Accordingly, the Guidance recommends manufacturers consider the safety and security of interoperable medical devices at all stages, including the design phase. First, manufacturers should undertake detailed risk-benefit assessments of their devices in the design process. Second, manufacturers should consider how they plan to update software, as well as maintain ongoing risk identification and mitigation procedures once the device has entered the market. Finally, manufacturers should plan communication of proper use and risks to users, both before sale, and on a continuing basis through the life of the device.
Design Considerations
More specifically, risk management of electronics incorporated into medical devices is part of a comprehensive quality system required by 21 CFR part 820, and the Guidance offers six factors manufacturers must consider in order to meet these requirements when designing interoperable medical devices.
These design factors are:
(1) Purpose of the Electronic Interface
Design considerations may differ for different types of electronic interfaces. Therefore, manufacturers should establish the purpose of the interface as they design it. Manufacturers should consider such factors as the type of devices they are connecting, and the type of data exchange taking place (e.g., sending or receiving).
(2) Anticipated Users
Manufacturers should make sufficient information available to allow safe use of the interface. The identity of the user matters for this inquiry. For example, patients may need detailed instructions on how to operate the device at home, whereas IT professionals may need instructions for maintaining the performance and security of the networks they manage.
3) Risk Management
The FDA recommends conducting a cost-benefit analysis of the device itself, as well as balancing accessibility to the network against security. Manufacturers should consider foreseeable uses, along with misuses of the network and device, and their ability to mitigate them. Manufacturers must ask questions of their devices and networks, such as does the interoperable interface reduce safety or performance? Can the network handle corrupted data? Manufacturers must continue to participate in risk management and maintenance of a device throughout its life cycle, as required by 21 CFR part 820.
(4) Verification and Validation
Testing ensures that devices function properly at all phases: prior to delivery, during the integration process, while in use, and through maintenance and release of software updates.
(5) Labeling Considerations
Labeling can reduce risk by communicating performance requirements and by explaining how users should properly connect to the interface. Labeling may appear in a product’s packaging or on a manufacturer’s website.
(6) Use of Consensus Standards
Implementing and adhering to recognized design standards should minimize system failure. However, the FDA does permit manufacturers to use their own standards, as opposed to consensus standards, so long as they are sufficiently rigorous. As Patel stated, “In case, problems or misuse of interoperable medical devices can be minimized by making the functional, performance, and interface requirements openly available to all users.”
The Guidance provides additional recommendations in the event that an interoperable medical device requires a premarket submission. The Guidance provides detailed premarket submission recommendations in four categories: Device Description, Risk Analysis, Verification and Validation, and Labeling.
Premarket Submissions
(1) Device Description
The device description in a premarket submission should describe “each externally-facing interface,” its purpose and anticipated users.
(2) Risk Analysis
Manufacturers should consider interoperability risks, risks from reasonably foreseeable misuse, and other foreseeable hazards.
(3) Verification and Validation
Manufacturers should include the results of electronic interface verification and validation testing in premarket submissions.
(4) Labeling
The FDA provides labeling recommendations to aide manufacturers in complying with 21 CFR 801 and 809 (mandatory provisions for any medical device being introduced into interstate commerce). The recommendations include specifying the purpose of the interface, intended users, recommended settings, a verification testing summary, and limitations and fault tolerance.
Conclusion
While nominally non-binding, the Guidance reflects the FDA’s current interpretation of regulations, which are binding (failure to follow the agency's Quality Systems Regulation (QSR) “adulterates” devices, and can result in their “seizure or injunction.”). The Guidance further reflects the FDA’s intention “to promote the development and availability of safe and effective interoperable medical devices.” As such devices become increasingly connected to each other, and to other technology, the Guidance is part of a larger effort, at both the federal and state level, to ensure safe medical devices.3
- U.S. Dep’t of Health & Human Servs., Food & Drug Admin., Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices – Guidance for Industry and Food and Drug Administration Staff (Sept. 6, 2017), fda.gov.
- Bakul Patel, Interoperability: The FDA’s Final Guidance on Smart, Safe, Medical Device Interactions, FDA Voice (Sept. 5, 2017), blogs.fda.gov.
- See, e.g., Internet of Medical Things Resilience Partnership Act of 2017, H.R. 3985, 115th Cong. (1st Sess. 2017); Information privacy: connected devices, S.B. 327, 2017-2018 Reg. Sess. (Cal. 2017).
Client Alerts 2017-260
