CLIA (Clinical Laboratory Improvement Amendments) Waiver Applications Final Guidances

Webinar
April 20, 2020

CLIA (Clinical Laboratory Improvement Amendments) Waiver Applications Final Guidances

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

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.

To ensure you are connected, please dial in 15 minutes prior to the start of the webinar.

U.S. Callers Dial: 888-390-1068
Conference Number: PWXW9502204
Passcode: 6352340

International Callers Dial: 1-212-547-0152
Conference Number: PWXW9502204
Passcode: 6352340

To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW9502204&p=6352340&t=c

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