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SEPARATE DEVICE APPLICATION FEE FOR CLIA SUBMISSIONS

This article was originally published in The Gray Sheet

Executive Summary

SEPARATE DEVICE APPLICATION FEE FOR CLIA SUBMISSIONS is provided for in a May 17 discussion draft of medical device user fee legislation. While the actual amount is left blank, the revised draft indicates that a separate fee will be levied "for an application submitted under section 353 of the Public Health Service Act," which is the Clinical Laboratories Improvement Amendments of 1988. The initial draft of the legislation made no mention of a specific fee for CLIA applications, instead grouping them with standard application fees ("The Gray Sheet" April 18, p. 3).
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