The U.S. Food and Drug Administration (FDA) finalized its recommendations on September 6, 2017 on how to secure interoperable medical devices’ interactions with other devices and information systems. The FDA’s initial guidance, drafted in January 2016, was designed to help manufacturers develop safe, secure information exchange systems in connected medical devices. The updated guidance incorporates comments received from industry, developers, and the public, and specifically recommends that all manufacturers of electronic medical devices take the following three steps:
- Design their devices with interoperability as an objective;
- Conduct appropriate verification, validation and risk management activities; and
- Clearly specify the relevant functional, performance, and interface characteristics to the user.
The final guidance also clarifies what information on interoperability should be included in premarket submissions, makes recommendations “for appropriate functional, performance, and interface requirements for connected devices to avoid errors and inadequate interoperability, such as differences in units of measure,” and advises designers and manufacturers to “provide information on a product’s functional performance and interface characteristics so that those using it with other devices and systems can do so safely.”
Connected medical devices can offer patients enhanced functionality and a better user experience. They can also help to optimize health outcomes and reduce costs. However, care must be taken to assure that all relevant safety and usability concerns are addressed. The FDA’s updated guidance is geared toward helping manufacturers maximize the safety and security of connected medical devices and to ensure that operating and interface requirements are transparent.