Guidance for Industry and Food and Drug Administration Staff; Administrative Procedures for CLIA Categorization; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Administrative Procedures for CLIA Categorization." The guidance describes FDA's current practices concerning the administrative aspects of categorizing commercially available in vitro diagnostic tests under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The guidance discusses what manufacturers should submit to help expedite CLIA categorization by FDA.