Medical Devices Draft Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver." FDA is issuing this draft guidance to propose alternative criteria for obtaining CLIA waiver to the criteria proposed by the Health Care Financing Administration (HCFA) and the Centers for Disease Control and Prevention (CDC). This draft guidance is neither final nor in effect at this time.