FDA to Extend Comment Period for Draft Guidances on CLIA Waiver Applications

The FDA is extending the comment period to March 30, 2018 for two draft guidances: 

• 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Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices - Draft Guidance for Industry and Food and Drug Administration Staff, and
• Recommendations for Dual 510(k) and CLIA Waiver by Application Studies - Draft Guidance for Industry and Food and Drug Administration Staff.

Instructions for submitting comments are available in the Federal Register under docket numbers FDA-2017-D-5570 and FDA-2017-D-5625.

The FDA published these two draft guidance documents on November 29, 2017 to help manufacturers of in vitro diagnostic (IVD) devices apply for and receive Clinical Laboratory Improvement Amendments (CLIA) waivers.

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Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Draft Guidance for Industry and FDA Staff is issued in accordance with section 3057 of the 21st Century Cures Act [P.L. 114-255].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The second guidance, Recommendations for Dual 510(k) and CLIA Waiver by Application Studies; Draft Guidance for Industry and FDA Staff, when finalized, will describe the agency’s expectations regarding study designs for generating data that supports both 510(k)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).

If you have general questions about these draft guidance documents or need assistance with a CLIA Waiver Application, please contact CLIA@fda.hhs.gov.