Stakeholders question FDA’s plan to release early warning on medical devices

Industry groups are responding to the FDA’s proposal to publicly release emerging safety signals before substantiation after the agency released draft guidance explaining its plans to track and release early medical device safety signals back in January.

The agency said it plans to release data related to medical devices used in clinical practices that the FDA is monitoring or analyzing when it has the potential to impact patient management decisions or alter benefit-risk profiles, has not been fully validated or confirmed and for which the agency does not have specific recommendations, according to the FDA’s official release.

Industry advocates responded to the FDA’s plans this week, with AdvaMed taking particular issue with the plan, saying the FDA failed to “articulate a reasonable basis to communicate emerging signals to the public.”

“In fact, FDA acknowledges that the release of an emerging signal to the public may deter use of a safe and effective medical device. A scientifically-driven regulatory agency should define clearly the strength of evidence and uncertainty that has resulted in the public communication of information about previously cleared or approved devices,” AdvaMed said in their comment to the FDA.

Advamed questioned the FDA’s authority to release such data, saying that incorrect information could be misleading and could negatively impact its use and patients’ well-being. The advocacy group said they were concerned that it would create “unnecessary confusion” for healthcare providers and patients.

The Medical Device Manufacturers Associations added their voice into the mix, saying that the U.S. sits as a world leader in medical device safety and questioning whether the new guidance would improve the system.

“In fact, there may be unintended consequences related to unvalidated information being relied upon by patients, providers and the public to make certain clinical decisions that may not be in a patient’s best interest,” the MDMA commented.

Novo Nordisk (NYSE:NVO) questioned whether the FDA would notify manufacturers prior to the public, and Abbott (NYSE:ABT) voiced its concerns that the notices be consistent and scientifically appropriate.

GE Healthcare responded with concerns over verification and validation of the signals before release, and Merck urged the FDA to revise the guidance to include cooperation with manufacturers throughout the process.

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