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FDA Holds Workshop on Proposed Regulatory Framework for Laboratory Developed Tests

21 January 2015

Medical Device Alert

In early January, the FDA held a two-day meeting on the Agency’s proposed regulatory framework for Laboratory Developed Tests (LDTs). The meeting follows an announcement in mid-2014 that the Agency plans to increase active oversight and regulatory of such tests.

Read more: FDA Holds Workshop on Proposed Regulatory Framework for Laboratory Developed Tests

The team

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