FDA Issues Draft Guidance on Design, Labeling for Interoperable Devices

With an eye toward ensuring the safe exchange of patient information between connected systems, the FDA is offering its thinking on ways to develop and design interoperable devices and providing recommendations on the content of premarket submissions and labeling.

As the agency notes in draft guidance issued Jan. 26, interoperability in healthcare can lead to enhanced patient care. “[However,] the failure to establish and implement appropriate functional, performance, and interface requirements during product development may lead to the exchange of inaccurate, untimely, or misleading information,” according to the draft guidance issued Jan. 26. “It may also lead to device malfunction, including the failure to operate, and can lead to patient injury and even death.”

To ensure proper information exchange, the agency encourages members of industry to consider the information model (data attributes), functional model (role played within the interoperable system) and architectural model (how the device is connected within the system) during the design and development phase.

Manufacturers should conduct testing that considers the risks associated with interoperability, reasonably foreseeable misuse, and reasonably foreseeable combinations of events that can result in a hazardous situation, says the draft guidance.

In addition, manufacturers should consider the following as they design their devices:

• The purpose of the electronic data interface;
• The anticipated users, e.g., biomedical engineers or IT professionals;
• Ways to mitigate risk;
• Verification and validation; and
• Labeling considerations.

The guidance document also provides the agency’s thinking on the contents of premarket submissions for interoperable medical devices. Submissions should describe how each interface is meant to be used and detail any limitations. They also should contain information to support claims that a device exchanges and uses information from other devices, technologies or products.

In addition, the document says labeling should include information on how to connect to the device. For a device that is meant to interact with only a few specific devices, the labeling should also explicitly state which items are and aren’t compatible.

Comments are due by March 28. Read the draft guidance “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices” here: www.fdanews.com/01-16-FDAInteroperability.pdf. — Jonathon Shacat