This is a companion article to the feature, “Reclassification of RIDTs.”
FDA concern about the performance of rapid influenza diagnostic tests (RIDTs) is rooted in the agency’s experience over a number of flu seasons when the tests did not live up to expectations. The agency’s extensive process for addressing its concerns kicked off in 2013, when an expert panel was convened to consider the scientific and regulatory issues related to RIDTs. FDA proposed RIDT reclassification and solicited public comments in 2014, and finally notified the public of its decision to reclassify RIDTs to Class II devices in early 2017. Following are some of the key milestones leading up to the implementation of new standards for RIDTs.1,7
June 13, 2013: FDA’s microbiology advisory panel considers relevant data and scientific issues, and recommends reclassifying RIDTs into Class II (special controls). The panel comprised six physicians and seven researchers, each considered “an authority on matters of influenza infection, treatment, epidemiology, and/or biology.”
May 22, 2014: FDA publishes a proposal to reclassify RIDTs and requests public comments, which are received from “device industry manufacturers, a consumer group, professional organizations, a healthcare organization, a device manufacturer association. and an individual consumer.”
January 12, 2017: FDA publishes Federal Register notice for reclassification of antigen-based RIDTs from Class I to Class II.
February 13, 2017: New special controls go into effect, with a 1-year grace period to allow manufacturers of currently marketed devices time to comply with the new requirements.
January 12, 2018: The 1-year grace period (from the date of Federal Register publication) ends and enforcement begins; all manufacturers are expected to meet the new Class II standards.
