A new special report from the Association for the Advancement of Medical Instrumentation (AAMI) lays out a framework for how the medical device industry and the Food and Drug Administration (FDA) could embrace a new—and shared—way of thinking when it comes to considering the benefits and risks of products already on the market. The goal of the document is to make for a clearer and more efficient way of reaching corrective and removal decisions when a problem emerges with a device that is already being sold and used. The challenge of postmarket actions, especially product removals, has long been a source of contention between regulators and manufacturers. The report—Postmarket Risk Management: A Framework for Incorporating Benefit-Risk Assessments into Correction and Removal Decisions—comes as the FDA has signaled a stronger interest in strengthening the postmarket observation of medical devices and at a time when the industry says there’s a need to streamline premarket decisions so innovative products can get to patients faster.
“In this environment, it is more important than ever that we have greater understanding and less acrimony,” said Mary Logan, who recently retired as the president and CEO of AAMI. “We saw a need for fresh perspectives and insights in considering how postmarket assessments ought to work. And, we realized that we needed to bring everyone together if we were going to find a meaningful and lasting solution.”
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