AAMI Releases Framework to Guide Device Benefit-Risk Assessments
A new AAMI report lays out a framework for how the medical device industry and the 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.
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