BEGIN:VCALENDAR VERSION:2.0 PRODID:-//wp-events-plugin.com//7.2.3.1//EN TZID:America/Phoenix X-WR-TIMEZONE:America/Phoenix BEGIN:VEVENT UID:1431@azbio.org DTSTART;TZID=America/Phoenix:20200414T120000 DTEND;TZID=America/Phoenix:20200414T133000 DTSTAMP:20200303T021708Z URL:https://www.azbio.org/events/fda-webinar-clinical-laboratory-improveme nt-amendments-clia-waiver-applications-final-guidances SUMMARY:FDA Webinar - Clinical Laboratory Improvement Amendments (CLIA) Wai ver Applications Final Guidances - Webinar - 14 Apr 20 12:00 DESCRIPTION:\n\n\n \;\n\n\n\n \;\n\n\n\n\n \;\n\n\n\n\n\n FDA Webinar - Clinical Laboratory Improvement Amendments (CLIA) Waiver Applica tions Final Guidances\n \n Date: \; April 14\, 2020\n Time: 12:00 P M- 1:30 PM AZ/MST (3:00 PM - 4:30 PM ET)\n\n\n \;\n\nSummary:\nOn Apri l 14\, 2020\, \;the U.S. Food and Drug Administration (FDA) will host a webinar for device manufacturers\, industry\, and other interested parti es to discuss and answer questions about the Clinical Laboratory Improveme nt Amendments (CLIA) Final Guidances:\n\n Recommendations for Clinical La boratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Man ufacturers of In Vitro Diagnostic Devices\n Recommendations for Dual 510( k) and CLIA Waiver by Application Studies\n\nBackground:\nOn February 25\, 2020\, the FDA issued two Clinical Laboratory Improvement Amendments (CLI A) Waiver Applications related final guidance documents.\n\nThe “Recomme ndations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Wai ver Applications for Manufacturers of In Vitro Diagnostic Devices” final guidance describes recommendations for CLIA waiver applications for in vi tro diagnostic (IVD) tests.\n\nIn accordance with the 21st Century Cures A ct\, the FDA revised “Section V. Demonstrating Insignificant Risk of an Erroneous Result – Accuracy” and issued the revisions as a separate dr aft guidance in 2018. The remainder of this final guidance\, except for th e 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 Diagnost ic Devices” issued in 2008.\n\nThe “Recommendations for Dual 510(k) an d CLIA Waiver by Application Studies” final guidance describes study des igns for generating data that may support both 510(k) clearance and CLIA w aiver. Specifically\, this guidance includes recommendations for designing a single set of comparison and reproducibility studies for Dual 510(k) an d CLIA Waiver by Application submissions.\nWebinar Details:\nRegistration is not necessary.\nDate: \;April 14\, 2020\nTime: 12:00 PM- 1:30 PM AZ /MST (3:00 PM - 4:30 PM ET)\n\nTo ensure you are connected\, please dial i n 15 minutes prior to the start of the webinar.\n\nU.S. Callers Dial:\n\n 888-390-1068\n Conference Number: PWXW9502204\n Passcode: 6352340\n\nIn ternational Callers Dial:\n\n 1-212-547-0152\n Conference Number: PWXW95 02204\n Passcode: 6352340\n\nTo view the slide presentation during the we binar: \;https://www.mymeetings.com/nc/join.php?i=PWXW9502204&\;p=6 352340&\;t=cExternal Link Disclaimer\n\nFollowing the webinar\, a trans cript\, recording and slides will be available at: \;http://www.fda.go v/CDRHWebinar\n\nWe appreciate your feedback on our webinar program. Follo wing 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.\n\nNote: The FDA does not provide Cont inuing Education Credits (CEU) or Certificates of Attendance for webinar a ttendance.\n\nTarget Audiences: Industry\, third party review organization s\, technology manufacturers (including start-up companies or labs)\, acad emic and research institutions\, health care facilities\, professional soc ieties\, foundations and other non-profits.\n\nIf you have any questions r egarding these final guidance documents\, please contact \;CLIA@fda.hh s.gov.\n\n CATEGORIES:webinars LOCATION:Webinar\, Anywhere\, USA\, United States X-APPLE-STRUCTURED-LOCATION;VALUE=URI;X-ADDRESS=Anywhere\, USA\, United Sta tes;X-APPLE-RADIUS=100;X-TITLE=Webinar:geo:0,0 END:VEVENT BEGIN:VTIMEZONE TZID:America/Phoenix X-LIC-LOCATION:America/Phoenix BEGIN:STANDARD DTSTART:20190415T120000 TZOFFSETFROM:-0700 TZOFFSETTO:-0700 TZNAME:MST END:STANDARD END:VTIMEZONE END:VCALENDAR