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Expert Analysis

Comparing FDA Medical Device Proposal With Global Rules

By William McConagha, Jennifer Bragg and Maya Florence (March 10, 2022, 5:28 PM EST) -- On Feb. 22, the U.S. Food and Drug Administration proposed a long-awaited rule to amend its quality system regulation, which is codified at Title 21 of the Code of Federal Regulations, Part 820, and sets forth current good manufacturing practice standards for medical devices....

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