The FDA has released a Class II Special Controls guidance, "Reagents for Detection of Specific Novel Influenza A Viruses." It was issued in combination with a Federal Register notice announcing the new classification.
The purpose of the guidance as a special control is to support the classification of reagents for the detection of specific novel influenza A viruses into Class II (special controls). Reagents for detection of specific novel influenza A viruses are devices intended for use in a nucleic acid amplification test to detect for specific virus RNA in humans. Detection of virus RNA aids in the diagnosis of influenza caused by the influenza A viruses.
The FDA stated that the viruses are new or re-emergent human strains of influenza A that cause cases or clusters of human disease as opposed to those human strains commonly circulating that cause seasonal influenza and to which human populations have residual or limited immunity, either by vaccination or previous infection.
The guidance states that any firm submitting a 510 (k) premarket notification for reagents for detection of specific novel influenza A viruses will need to cover issues covered in the special control guidance. Generally, the firm must show that its device meets the recommendation of the guidance or in some other way produces equivalent assurances of safety and effectiveness. Additionally, the device must satisfy the additional special control specified in the classification regulation requiring that distribution be limited to laboratories with experienced personnel who have training in " standardized molecular testing procedures and expertise in viral diagnosis and appropriate biosafety equipment and containment."
For more information visit, http://www.fda.gov/cdrh/oivd/guidance/1596.html (http://www.fda.gov/cdrh/oivd/guidance/1596.html). ()a href="http://www.fdanews.com/ddl" target=_blank>