Medical devices; immunology and microbiology devices; classification of reagents for detection of specific novel influenza A viruses. Final rule.
The Food and Drug Administration (FDA) is classifying Reagents for detection of specific novel influenza A viruses into class II (special controls). Special controls that will apply to the device are the guidance document entitled, "Class II Special Controls Guidance Document: Reagents for Detection of Specific Novel Influenza A Viruses" and limitations of distribution of these reagents. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is a special control for this device.
D018795:Device Approval / Q000331:legislation & jurisprudence; D004869:Equipment Safety / Q000145:classification; D006801:Humans; D053124:Influenza A Virus, H5N1 Subtype / Q000302:isolation & purification; D009980:Influenza A virus / Q000302:isolation & purification; D016133:Polymerase Chain Reaction / Q000145:classification* / Q000295:instrumentation; D011933:Reagent Kits, Diagnostic / Q000145:classification* / Q000821:virology; D014481:United States; D014486:United States Food and Drug Administration; D014773:Virology / Q000145:classification / Q000295:instrumentation* / Q000331:legislation & jurisprudence
D011933:Reagent Kits, Diagnostic