A Class II special controls FDA guidance, "Reagents for Detection of Specific Novel Influenza A Viruses," was released in the Federal Register.
The guidance classifies reagents for detecting specific novel influenza A viruses as Class II (special controls) devices. Reagents for detecting these virus are used in nucleic acid amplification tests to detect specific virus RNA in humans, which aids in diagnosing the type of influenza caused by influenza A.
The FDA stated that these viruses are new or reemergent human strains of influenza A, as opposed to the commonly circulating human strains that cause seasonal influenza.
Any firm submitting a 510(k) premarket notification for these reagents will need to show their device meets the recommendation of the guidance or provide equivalent assurances of its safety and effectiveness.
The device also must satisfy the additional special control 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," the guidance states.
FDA believes that, when combined with general controls, special controls will be sufficient to provide assurance of the safety and effectiveness of reagents for detection of these viruses.
In a related action, the FDA issued a final rule that classifies these reagents as Class II devices, which becomes effective April 21. Devices not in commercial distribution before 1976 are classified automatically by statute as Class III without any FDA rulemaking process, and remain Class III unless they are reclassified after premarket approval.
For more information on the guidance and rule, visit http://www.fda.gov/cdrh/oivd/guidance/1596.html (http://www.fda.gov/cdrh/oivd/guidance/1596.html) and http://www.fda.gov/OHRMS/DOCKETS/98fr/06-2742.htm (http://www.fda.gov/OHRMS/DOCKETS/98fr/06-2742.htm)