The Food and Drug Administration (FDA) released two final guidance documents designed to help manufacturers of in vitro devices gain regulatory approval.
In the first guidance, the FDA developed recommendations for manufacturers of in vitro diagnostic devices seeking to apply for a CLIA waiver. The recommendations, which were required by the 21st Century Cures Act, revise a section of the Clinical Laboratory Improvement Amendments (CLIA), “Demonstrating Insignificant Risk of an Erroneous Result – Accuracy.”
The FDA grants manufacturers waivers from CLIA for tests that are "simple" and have "an insignificant risk of an erroneous result."
The second guidance explains how to design studies that may generate data supporting both a 510(k) clearance and a CLIA Waiver. Manufacturers use these designs if they want to apply for both regulatory approvals concurrently.
“Use of the Dual 510(k) and CLIA Waiver by Application pathway is optional; however, FDA believes this pathway is in many instances the least burdensome and fastest approach for manufacturers to obtain a CLIA waiver at the same time as 510(k) clearance for new In Vitro Diagnostic (IVD) tests. FDA believes increased use of this pathway will speed up the process of bringing simple and accurate IVD tests to CLIA-waived settings, which will better serve patients and providers,” the FDA said in announcing the guidance.
The FDA’s staff will host a webinar about the two documents on April 14, 2020.
