FDA ISSUES FINAL RULE, GUIDANCE ON CYSTIC FIBROSIS ASSAYS

In a final rule published in the Jan. 10 Federal Register, the FDA has classified quality control material for cystic fibrosis nucleic acid assays into Class II, or special controls. The agency also published related guidance.

The assays are designed to monitor the reliability of a test system by "detecting analytical deviations such as those that may arise from reagent or instrument variation in genetic testing," the FDA said. The devices include recombinant, synthetic and cell line-based DNA controls.

The final rule is the result of the FDA's classification of Maine Molecular Quality Controls' INTROL CF Panel I Control device, which was originally approved as a Class III device in September 2006.

The guidance, "Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays," can be accessed at www.fda.gov/OHRMS/DOCKETS/98fr/06d-0515-gdl0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0515-gdl0001.pdf).