The guidance provides details on when and how the agency categorizes in vitro diagnostic devices under the Clinial Laboratory Improvement Act.
By Jim Dickinson
On March 12, FDA published a guidance document, "Administrative Procedures for CLIA Categorization," to update an earlier document on waiver applications for manufacturers of in vitro diagnostic (IVD) devices.
The update includes information about FDA’s internal administrative processes, including CDRH’s e-copy program that is voluntary for Clinical Laboratory Improvement Act (CLIA) categorization.
The guidance says CLIA categorization of IVD tests is determined at the time of review of a premarket notification submission (510(k)) or a PMA. The agency says it determines test complexity by reviewing the package insert test instructions in the premarket submission. Tests that are not waived by regulation and are not cleared or approved for home use or for over-the-counter use may be categorized either as moderate or high complexity.
Jim Dickinson is MD+DI's contributing editor.