Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays." This guidance document describes a means by which quality control material for cystic fibrosis nucleic acid assays may comply with the requirement of special controls for class II devices. It includes recommendations for validation of performance characteristics and recommendations for product labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify quality control material for cystic fibrosis nucleic acid assays into class II (special controls). This guidance document is being immediately implemented as the special control for quality control material for cystic fibrosis nucleic acid assays, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).