Noting that it was “profoundly concerned” about the proposal, AdvaMed stated that “emerging signal communications issued prior to the agency having adequate, fully analyzed, validated and confirmed evidence, and without appropriate instructive recommendations, will create unnecessary confusion for health care providers and patients, and could have unintended consequences including an adverse impact on public health and long-lasting reputational damage to valuable devices.”

The association stated information that turned out to be “incorrect, incomplete, or misleading will undermine public confidence, is highly unlikely to promote the public health, and will likely lead to inappropriate changes in medical care.”


GE Healthcare noted that the draft guidance didn’t include “adequate verification and validation” of emerging signals before public release, according to a news report on the Regulatory Affairs Professionals Society (RAPS) website.

The firm urged the FDA to consider how it would manage communication of early stage information that would have clinical impacts on patients.

“An example to consider was the experience with cardiac leads where the initial reaction was to remove the implanted devices from patients. Unfortunately, the surgical procedure to explant the leads actually had greater risks and resulted in more fatal injuries to patients than had the devices remained implanted,” GE Healthcare’s statement noted.

Novo Nordisk asked whether manufacturers would be notified ahead of time if the FDA was going to make a public notification about a possible emerging signal and whether the companies would be able to appeal if they disagreed.

Novo Nordisk also cautioned that the FDA must consider that early signal communications “may lead to over-reporting of cases with the device. Therefore, the increased rate may not be a true reflection of the incidence rate.”

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