'A Sea Change': Device Center Compliance Chief Touts US FDA's Benefit-Risk Concepts – But Will Manufacturers Buy In?
• By Shawn M. Schmitt
FDA compliance head Robin Newman is asking manufacturers to share information on troublesome devices to help the agency make benefit-risk decisions that weigh product availability and regulatory compliance. But an industry survey finds that only 17% of firms are willing to hand over such potentially sensitive information. Nevertheless, the agency believes it's vitally important for device-makers to be more forthcoming with data that supports well-informed benefit-risk conclusions, made in the best interest of patients and manufacturers. Driving the data-sharing discussion is a December guidance from FDA that outlines a broad framework for considering benefit-risk factors – a document that Newman says is "a sea change" for how industry and the agency can work hand-in-hand on benefit-risk analyses.
Data culled from manufacturers about nonconforming medical devices is a helpful ingredient for US FDA to use as it makes key benefit-risk decisions weighing product availability and regulatory compliance issues.
But a recent industry survey suggests that some firms are leery of sharing what they see as sensitive information with FDA – data they believe could lead the agency to...
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