Subject: Draft Guidances and Webinar on CLIA Waiver Applications
Today the FDA published two draft guidance documents to help manufacturers of in vitro diagnostic (IVD) devices apply for and receive Clinical Laboratory Improvement Amendments (CLIA) waivers. The comment period for each draft guidance document will be 60 days.
The first guidance document is 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Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Draft Guidance for Industry and FDA Staff. This draft guidance is issued in accordance with section 3057 of the 21st Century Cures Act [P.L. 114-255]. When finalized, this will represent FDA’s thinking regarding the appropriate use of comparable performance between a user in a waived facility and a user in a moderately complex laboratory to demonstrate accuracy. When final, this content will revise “Section V. Demonstrating Insignificant Risk of an Erroneous Result — Accuracy” of the guidance Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices (2008).
The second guidance is the Recommendations for Dual 510(k) and CLIA Waiver by Application Studies; Draft Guidance for Industry and FDA Staff. This draft guidance, when finalized, will describe the agency’s expectations regarding study designs for generating data that supports both 510(k) clearance and CLIA Waiver by Application. The FDA believes that increased use of this pathway will speed up the process of bringing simple and accurate IVD devices to CLIA waived settings, which will better serve patients and providers.
For more information about the CLIA program, please see Clinical Laboratory Improvement Amendments (CLIA).
On January 8, 2018, the FDA will host a webinar for industry to discuss and answer questions about these draft guidance documents. FDA employees are welcome to participate in this webinar and may join in listen-only mode. No registration is required.
- Date: 1/8/2018
- Time: 3:00 – 4:30 PM EST (To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar)
- To hear the presentation and ask questions:
Dial: 800-369-2039, International Callers Dial: 1-517-308-9315; Conference Number: PWXW6320282; Passcode: 5179628
- To view the slide presentation during the webinar: https://www.mymeetings.com/nc/
- Following the webinar, a transcript, audio recording, and slides will be available at: http://www.fda.gov/
CDRHWebinar. The slide presentation will also be available at this site on the morning of the webinar.
If you have general questions about these draft guidance documents or need assistance with a CLIA Waiver Application, please contact CLIA@fda.hhs.gov.