FDA-FRAMEWORK Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories - Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)

FDA-FRAMEWORK - 2014 DRAFT - DRAFT
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Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories - Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)


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Document Number

FDA-FRAMEWORK

Revision Level

2014 DRAFT

Status

Draft

Publication Date

Oct. 3, 2014

Page Count

41 pages