In final guidance published on September 6, the U. S.
Food and Drug Administration (FDA) provided manufacturers with
recommendations for ensuring interoperable medical devices are
safely and securely designed and developed through a recently
published final guidance. The guidance also provides
recommendations for labeling an interoperable device and clarity
regarding the type of content manufacturers should include in a
pre-market submission.
"Interoperability" refers to the ability of two or more
products, technologies, or systems to interconnect and use
exchanged information such as by displaying, storing, interpreting,
or analyzing the shared information. The guidance suggests that the
keys to assuring the safety and effectiveness of interoperable
medical devices are: (i) designing systems with interoperability as
an objective; (ii) conducting verification, validation and risk
management; and (iii) specifying the relevant functional,
performance, and interface characteristics in a user-friendly
manner through labeling.
Manufacturers are advised that when they design and develop
devices, they should carefully consider the needs of the
anticipated users of the electronic interface (for example, IT
personnel or clinician) and the specific purpose of the
interoperability. The FDA also recommends that as part of the
development process, manufacturers anticipate and address the
complex risks associated with interconnectivity in a system of
multiple medical devices.
In developing interoperable medical devices, manufacturers should
also consider prior FDA guidance aimed at safeguarding against
breaches, such as the cybersecurity guidance for medical devices
published in December 2016 (discussed
here) .
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