Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Doc

• Date: November 08, 2009
• Source: www.fda.gov

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA.’’ This guidance document describes a means by which an enterovirus nucleic acid 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 codifying the classification of the enterovirus nucleic acid assays into class II (special controls). This guidance document is immediately in effect as the special control for an enterovirus nucleic acid assay, but it remains subject to comment in accordance with the agency’s good guidance practices (GGPs)

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