Regulatory Editor

The final FDA guidance for interoperable medical devices has emerged only 18 months after issuance of the draft, but the agency maintained language stipulating that verification and validation should ensure that those devices "continue to work while in use" despite concerns that providers have a large influence on the continued interoperability of those devices.

The FDA released the draft guidance in January 2016, at which point the agency indicated that developers would have to demonstrate that device design has been undertaken with interoperability in mind. However, there was even then support from some quarters for the draft guidance's provisions dealing with verification and validation, including from Julian Goldman, director of the device interoperability program at Massachusetts General Hospital in Boston. (See BioWorld MedTech, Jan. 27, 2016.)

Among those who commented on the draft guidance was Patrick Hope, executive director of the Medical Imaging & Technology Alliance, who expressed concern about "the broad range of interfaces that might fall into the scope" of the draft. Hope said the draft's provisions pertaining to verification and validation failed to appreciate that providers "have dozens of interoperable medical devices" at their facilities, and that "there are changes almost daily" in the configuration via additions and removals.

Hope argued that verification/validation "cannot be the (sole) responsibility of a single manufacturer" because of the variable configuration question, recommending that the FDA "provide clear boundaries for the responsibilities of manufacturers for the use phase of the devices." Nonetheless the agency held its ground, sustaining the language dealing with the statement that verification and validation should ensure that the electronic interfaces in their devices and systems "continue to work while in use," although the final adds the notation that verification and validation should continue "through maintenance and release of software updates" as well.

The statement of scope differs little between draft and final guidance, the principle difference being that the final adds the suggestion that the manufacturer specify the type of physical connection to be used to support the electronic interface. The draft characterizes the electronic data interface as including "the data schema which defines the information content," a phrase that is omitted in the final.

The discussion pertaining specifically to design considerations in the draft includes a reference to the risks associated with "inappropriate access to the device," a phrase that does not appear in the final. The final includes a mention of consensus standards to establish interoperability, which does not appear in the same portion of the draft. Both the draft and final versions point to the need for synchronization as a means of ensuring that the time stamps on data collected from multiple devices – such as a pulse oximeter and an electrocardiogram – are consistent.

Another feature of the final guidance that does not appear in the draft is the notation that testing should simulate real-world use of the device, but the final further includes the suggestion that the sponsor include in premarket submissions information on methods used for time synchronization. /p>

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