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Zdrowie i gospodarka · 31/10/2003

Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Endotoxin Assay; Availability

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Class II Special Controls Guidance Document: Endotoxin Assay." This guidance document describes a means by which an endotoxin assay may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify the endotoxin assay into class II (special controls). This guidance document is effective immediately as the special control for the endotoxin assay, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).

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