Abstract
An ad hoc committee of the Board of Directors of the Society for Inherited Metabolic Disorders (SIMD) developed the following commentary in response to the Food and Drug Administration's request for comments at a public meeting held on July 19–20, 2010 in Hyattsville, MD on FDA oversight of laboratory-developed testing (LDT). The Board recognized the importance of being heard on this very important topic of interest to all who are stakeholders in LDT. The President of the SIMD, Georgirene D. Vladutiu, gave a brief presentation at the open meeting both as an individual stakeholder and as a representative for the SIMD. The following is a summary of her remarks and is posted as part of the FDA docket for comments on August 15, 2010.
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