Zdrowie i gospodarka · 14/08/2000

Draft Guidance for Industry on Administrative Procedures for CLIA Categorization; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry entitled "Guidance for Administrative Procedures for CLIA Categorization." The Center for Devices and Radiological Health is issuing this draft guidance document to provide information to manufacturers on how to submit requests for complexity categorization under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and how FDA will notify the manufacturer of the complexity categorization.