By Allyson B. Mullen –
On September 6, 2017, FDA issued the final guidance “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.” The final guidance can be found here. The document provides guidance regarding interoperable devices, which it defines as devices “that have the ability to exchange and use information through an electronic interface with another medical/non-medical product, system, or device.” FDA issued a draft of this guidance on January 26, 2016. We previously blogged on the draft guidance here.
The final guidance is generally unchanged from the draft. There are, however, a few notable differences:
The final guidance acknowledges that design considerations may be different for different types of devices. This is a good sign that FDA acknowledges that interoperability is not a one-size-fits-all requirement.
The final guidance includes an additional design factor to consider regarding interoperability, “the transmission of metadata (e.g., unique device identifier (UDI), software version, configurations, settings).”
With regard to the anticipated users, the guidance adds that “patients may need specific instructions on how to use their device in a home environment.”
The final guidance emphasizes the need to perform risk analysis. For certain devices, FDA currently requests the risk analysis as part of the 510(k) submission. It will be interesting to see if FDA begins asking for the risk analysis for interoperable devices.
With regard to the types of verification and validation that a manufacturer should perform, the final guidance includes two additional points to consider, “assur[ing] that reasonably foreseeable interactions do not cause incorrect operation of other networked systems; and conduct[ing] testing that simulates real-world use of the device.”
The final guidance indicates that labeling considerations with regard to interoperability can be addressed through “materials within the package of the device, the instructions for use, or device-specific information posted on the manufacturer’s website.” (emphasis added.) FDA’s authority to regulate information on a company’s website as labeling is not clear cut. Therefore, it is interesting that the guidance makes such an affirmative assertion that labeling statements regarding interoperability may appear on a company’s website.
One final interesting point to note, the final guidance includes the following statement:
FDA recognizes and anticipates that the agency and industry may need up to 60 days to perform activities to operationalize the policies within the guidance. If new information regarding device interoperability as outlined in this guidance is not included in a premarket submission received by FDA before or up to 60 days after the publication of this guidance, CDRH staff does not generally intend to request such information during the review of the submission.
While it is generally understood, at least in industry, that it takes time to comply with new FDA guidances, it is unusual for a guidance to expressly allow for a lead-in period. However, in some instances, the Agency has been in a hurry to implement new guidances. We think this language is a good sign that FDA is acknowledging that it will take time for manufacturers to comply with new guidance (even though the guidance is not technically binding).