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Webinar Materials

• Printable Slides
• Transcript
• Presentation

On January 9, 2019, the FDA will host a webinar for industry to discuss and answer questions about two draft guidance documents intended to help manufacturers of in vitro diagnostic (IVD) devices apply for and receive Clinical Laboratory Improvement Amendments (CLIA) waivers.

On November 28, 2018 the FDA published two draft guidance documents:

• Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Draft Guidance for Industry and FDA Staff; and
• Recommendations for Dual 510(k) and CLIA Waiver by Application Studies; Draft Guidance for Industry and FDA Staff

These draft guidances are not final and not in effect at this time.

Webinar Details:

Date: Wednesday, January 9, 2019
Time: 1:00 – 2:30 PM Eastern Time
To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar

NOTE: You must dial-in to hear the presentation and ask questions:

U.S. Callers Dial: 888-324-9236
CONFERENCE NUMBER: PWXW8407564
PASSCODE: 2798264

International Callers Dial: 1-415-228-3923
CONFERENCE NUMBER: PWXW8407564
PASSCODE: 2798264

To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW8407564&p=2798264&t=c

Following the webinar, a transcript, audio recording and slides will be available at: https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm411063.htm

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

NOTE: The FDA does not provide Continuing Education Credits (CEU) or Certificates of Attendance.

If you have any questions, please contact [email protected] or the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health at 1-800-638-2014, 301-796-7100 or [email protected].

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