The Food and Drug Administration (FDA) recently issued draft guidance on interoperable medical devices, entitled "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices."1 An interoperable device is defined as a medical device that has the "ability to exchange and use information through an electronic data interface with another medical device, product, technology, or system," or essentially, a medical device that electronically communicates with other products or technologies. For example, an infusion pump may receive patient data from several devices, such as a pulse oximeter, ventilator, and blood pressure monitor, and then use this data to change infusion pump settings.
This guidance, when finalized, is intended to provide interoperable medical device manufacturers with design considerations, content to include in a pre-market submission, and labeling recommendations. The guidance focuses on mitigating the risks associated with the electronic data interface that is incorporated into the medical device, as the FDA is clear that safety is the most important consideration for interoperable devices.
Design Considerations for Interoperable Devices
The draft guidance discusses five considerations that device manufacturers should address when designing interoperable devices:
- Purpose of the electronic data interface—including the purpose of the data exchanges taking place and the types of devices this particular device is meant to connect to;
- Anticipated users (e.g., IT professionals, medical device designers, clinical users)—the risk management strategies chosen by manufacturers should address risk associated with the use of the device by these anticipated users, including reasonably foreseeable misuse of the device;
- Security and risk management—manufacturers should conduct a risk analysis and appropriate testing to determine the risks associated with interoperability for the device and then determine how to mitigate those risks;
- Verification and validation to ensure devices work correctly at all stages of use; and
- Labeling considerations—devices should include the information that the anticipated users need to connect "predictably and safely" for the intended purpose
The FDA's guidance states that these considerations should be "tailored to the selected interface technology, and the intended use and use environments for the medical device."
Content for Pre-market Submissions
While not all interoperable devices may require a pre-market submission to the FDA, the FDA's draft guidance includes recommendations for the content that should be included in a pre-market submission for an interoperable device. The FDA suggests that interoperable device manufacturers reference the Design Considerations for Interoperable Devices set forth above in preparing a pre-market submission. The FDA also provides additional recommendations for device manufactures to appropriately capture and document this information prior to the pre-market submission.
The FDA's draft guidance also includes recommendations for interoperable device manufacturers to consider when preparing the device's labeling prior to introduction into the marketplace. Generally speaking, information about the electronic data interface of the device should be included in the labeling. The draft guidance also sets forth a detailed list of specific information that the FDA recommends to include in the interoperable device labeling.
Finally, the FDA's draft guidance encourages the use of consensus standards in designing and developing interoperable medical devices. However, the guidance clarifies that manufacturers may still choose to use their own design preferences in designing interoperable devices, rather than relying on a published consensus standard recognized by the FDA. The draft guidance will be available for public comment until March 26, 2016.