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Expert Analysis

Digging Into The Debate On FDA's Proposed Lab Test Rule

By Benjamin Zegarelli, David Gilboa and Joanne Hawana ( January 3, 2024, 2:21 PM EST) -- The U.S. Food and Drug Administration's proposed rule published on Oct. 3, 2023, makes a modest 10-word amendment to a single provision of the agency's extensive regulations pertaining to medical devices. However, that single modification represents a sea change in device regulation....

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