The U.S. Food and Drug Administration (FDA) on Sept. 6, 2017, published the final version of its guidance on Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices. This final guidance is the latest in a flurry of FDA publications over the past few years addressing the myriad issues associated with the burgeoning field of digital health, as the FDA attempts to keep up with innovations in health information technology. The FDA also has issued final guidance on topics such as medical device data systems, mobile medical apps and medical device accessories. The industry is eagerly awaiting additional guidance documents on topics such as clinical decision support software.
Interoperable devices are medical devices, as defined under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), that have the ability to exchange and use information through an electronic interface with another medical or non-medical product, system or device. The definition is broad, and systems that include such devices may be stand-alone, may broadcast data so that anyone can access it, may connect and exchange information with other medical or non-medical devices or technologies or systems composed of multiple such components. The functionalities can be as simple as one-way communication of information to another device, or more complex interactions such as exerting control over other devices.
FDA Recommendations to Consider
The 18-page final guidance does not address a completely new type of device, but rather provides a set of FDA recommendations that apply to any device with interoperability, whether existing or new. The document provides advice to device manufacturers regarding things that they should consider to provide the FDA reasonable assurance of the safety and effectiveness of their product, whether the product requires pre-market approval or not. The document addresses:
- designing systems with interoperability as an objective
- conducting (and documenting) appropriate verification, validation and risk management activities
- specifying the relevant functional, performance, and interface characteristics to the user(s), such as through the device's labeling
- for products that do require pre-market approval (PMA) or clearance, the appropriate content a device manufacturer should provide to FDA in its 510(k) or PMA regarding the device's interoperability
Manufacturers of interoperable devices who have made pre-market submissions prior to, or within 60 days after, the publication of the final guidance do not need to amend their submissions to address topics contained in the guidance, but the FDA will consider any information relevant to the guidance to the extent it is already included.
Additional Information for Pre-Market Submissions
The FDA recommends additional information be incorporated in any required pre-market submission for an interoperable medical device. Among the highlights of information to include are:
- A discussion of each externally facing interface found on the device, its purpose, and its anticipated users, as well as a description of how each interface is meant to be used and/or the limitations of its use.
- If applicable, a description of any information exchanged with other devices, products, technologies or systems, how it is exchanged, and the impact the information has on the device itself, or other devices.
- For devices subject to the risk analysis in 21 C.F.R. §820.30(g), an analysis considering risks associated specifically with interoperability, including the interface itself, the intended connections, and any effects the connections may have on intended performance.
- For devices that are meant to connect with only a few specified devices, submission of complete documentation of testing of the product interface with all such devices may be warranted, whereas for devices meant to be operated with a large class of other devices or technologies, testing of a representative sample, or a summary of testing, may suffice for purposes of validation.
- The manufacturer should consider what information to include on the proposed labeling regarding the electronic interface of the device, including with regard to the different types of users who may interact with it. Separate instructions may be useful for different types of users; for example instructions for patients versus for hospital IT personnel or technicians.
The guidance is detailed, and provides numerous examples to assist manufacturers through the process. Thus, a close read by manufacturers with their particular products in mind is warranted.