Guidance Aids Firms Seeking Waivers for ‘Simple,’ Less Risky IVDs

Makers of in vitro diagnostic devices (IVDs) may find it easier to file for Clinical Laboratory Improvement Amendments (CLIA) waivers thanks to a new guidance.

Under CLIA, the FDA can determine whether tests are “simple” and have “an insignificant risk of an erroneous result,” making them eligible for waivers. The guidance recommends ways to demonstrate a device meets these criteria.

Some of the changes from a 2001 draft guidance include additional emphasis on quality control procedures, recognition that reference methods may not be available for all device types, greater emphasis on intended users during device testing, updated study recommendations, and greater emphasis on scientifically based flex studies and validation and verification studies linked to each device’s risk assessment.

The guidance, “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices,” can be seen at www.fda.gov/OHRMS/DOCKETS/98fr/08-d-0031-gdl0001.pdf.