FDAnews Device Daily Bulletin

AdvaMed Warns FDA’s Intended Use Final Rule Could Hinder Device Communications

Aug. 2, 2017

AdvaMed expressed “grave concerns” about the FDA’s final rule clarifying when tobacco products are regulated as medical devices, saying the rule’s definition of “intended use” is overbroad and will restrict communications.

In a written comment to the agency, the industry group said the rule is likely to confuse device manufacturers because of how it regulates communications on approved and off-label device uses. The ambiguity could hinder important communications with other stakeholders, the group said, putting the rule in violation of agency protocols on non-misleading statements.

Routine industry communications often lead to discussions of both approved and unapproved device uses, AdvaMed said, from educational presentations on clinical trial data related to investigational uses, to feedback on research from healthcare development, to continual back-and-forth communication about real-world use of devices.

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