Search Results for CLIA Waiver by Application

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FDA Issues Two Guidances on CLIA Waiver Applications, 510(k) Dual Submissions By Michael Mezher - Published 28 November 2017

The US Food and Drug Administration (FDA) on Tuesday issued two draft guidances aimed at updating its recommendations for in vitro diagnostics (IVDs) seeking a waiver from requirements under the Clinical Laboratories Improvement Amendments (CLIA) in line with provisions of the 21st Century Cures Act and the recently reauthorized Medical Device User Fee Amendments (MDUFA IV).

Categories: News, US, FDA, In vitro diagnostics, Submission and registration

Tags: CLIA Waiver, CLIA Waiver by Application, IVDs, Dual Submissions

CLIA Waiver Decisions: FDA Begins Posting Summaries By Michael Mezher - Published 03 October 2017

The US Food and Drug Administration (FDA) on Friday began posting decision summaries for its Clinical Laboratory Improvement Amendments (CLIA) waiver decisions for in vitro diagnostics (IVDs) as part of a pilot to boost transparency.

Categories: News, US, FDA, In vitro diagnostics, Submission and registration

Tags: CLIA, CLIA Waiver by Application