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FDA Cites Safety Issues, Reclassifies C. difficile Toxin Gene Amplification Assays
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The FDA has issued a final order and a special controls guideline to classify toxin gene amplification assays for the detection of Clostridium difficile as class II (special controls) devices “to provide a reasonable assurance of safety and effectiveness.”
The special controls guideline “identifies measures that FDA considers as mitigations to the risks to health associated with these devices.” Companies that submit a 510(k) premarket notification for a C. difficile toxin gene amplification assay will now have to comply with these mitigation measures, which include performing a risk analysis before submission, or demonstrate “at least equivalent assurance of safety and effectiveness” using alternative measures.
The four risks to health identified by the FDA to be associated with use of a C. difficile toxin gene amplification assay include false-negative results, which could delay “a definitive diagnosis, appropriate treatment, infection control and prevention measures”; false-positive results, which “could lead to unnecessary or inappropriate treatment or unnecessary control and prevention actions;” device failure, including failure of reagents, instrumentation, data management or software, which “could delay diagnosis and could require additional specimen collection”; and failure of proper interpretation of results, which “may lead to incorrect patient management decisions.”
Besides the risk analysis, other mitigation measures in the guideline include specific device description requirements in the 510(k), specific requirements for performance studies and device labeling requirements.
The order becomes effective Sept. 28, and the classification was applicable beginning April 30, 2012.
Reference:
www.regulations.gov/#!documentDetail;D=FDA-2015-N-2963-0001.