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Webinar Materials

• Presentation
• Printable Slides
• Transcripts

Summary:

On April 14, 2020, the U.S. Food and Drug Administration (FDA) will host a webinar for device manufacturers, industry, and other interested parties to discuss and answer questions about the Clinical Laboratory Improvement Amendments (CLIA) Final Guidances:

• Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
• Recommendations for Dual 510(k) and CLIA Waiver by Application Studies

Background:

On February 25, 2020, the FDA issued two Clinical Laboratory Improvement Amendments (CLIA) Waiver Applications related final guidance documents.

The “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” final guidance describes recommendations for CLIA waiver applications for in vitro diagnostic (IVD) tests.

In accordance with the 21st Century Cures Act, the FDA revised “Section V. Demonstrating Insignificant Risk of an Erroneous Result – Accuracy” and issued the revisions as a separate draft guidance in 2018. The remainder of this final guidance, except for the Section V revisions, has not been substantially changed from the final guidance “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” issued in 2008.

The “Recommendations for Dual 510(k) and CLIA Waiver by Application Studies” final guidance describes study designs for generating data that may support both 510(k) clearance and CLIA waiver. Specifically, this guidance includes recommendations for designing a single set of comparison and reproducibility studies for Dual 510(k) and CLIA Waiver by Application submissions.

Following the webinar, a transcript, recording and slides will be available at: http://www.fda.gov/CDRHWebinar

We appreciate your feedback on our webinar program. Following the webinar, we will provide a link to a short survey about your FDA CDRH webinar experience, which should take no more than 5-10 minutes to complete. Your responses are confidential and will be used to help ensure the quality of our webinar program.

Note: The FDA does not provide Continuing Education Credits (CEU) or Certificates of Attendance for webinar attendance.

Target Audiences: Industry, third party review organizations, technology manufacturers (including start-up companies or labs), academic and research institutions, health care facilities, professional societies, foundations and other non-profits.

If you have any questions regarding these final guidance documents, please contact [email protected].

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