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Expert Analysis

FDA's Proposed Medical Device Rule Is Promising, But Hasty

By Joshua Oyster, Beth Weinman and Austin Laroche ( March 23, 2022, 5:05 PM EDT) -- On Feb. 23, the U.S. Food and Drug Administration published its long-awaited proposed rule[1] to harmonize its regulations governing current good manufacturing practices for medical devices with the International Organization for Standardization's consensus standard for device quality management systems used by regulatory authorities in many countries throughout the world, known as ISO 13485.[2]...

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