A final guidance has been posted titled, "Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile." This special controls guideline was developed to support the classification of a Clostridium difficile toxin gene amplification assay into class II (special controls).
This guideline identifies measures that FDA considers as mitigations to the risks to health associated with these devices and that provide a reasonable assurance of safety and effectiveness. Firms submitting a 510(k) premarket notification for a Clostridium difficile toxin gene amplification assay will need either to (1) comply with the particular mitigation measures set forth in the special controls guideline or (2) use alternative mitigation measures, but demonstrate to the Agency's satisfaction that those alternative measures identified by the firm will provide at least equivalent assurance of safety and effectiveness.
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