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Zdrowie i gospodarka · 3.02.1999

Points To Consider Guidance Document on Assayed and Unassayed Quality Control Material; Draft; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Points To Consider Guidance Document on Assayed and Unassayed Quality Control Material.'' This draft guidance is neither final nor is it in effect at this time. This draft guidance is intended to provide assistance to manufacturers of in vitro diagnostic quality control materials. It complements the existing guidance on labeling of these devices entitled `` Points to Consider for Review of Calibration and Quality Control Labeling for In Vitro Diagnostic Device.''

Source: Federal Register — Food and Drug AdministrationOpen original release →