Establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of human papillomaviruses: guidance for Industry and Food and Drug Administration staff
Guidance for industry
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Devices and Radiological Health (U.S.). Office of In Vitro Diagnostics and Radiological Health, issuing body.
Silver Spring, MD : Center for Devices and Radiological Health, September 15, 2017