This is a companion article to the feature, “Reclassification of RIDTs.”

Reclassified for the US market as Class II devices, rapid influenza diagnostic tests (RIDTs) must now meet special controls designed to improve their performance to better address public health needs in an ever-evolving influenza landscape.6 The new requirements include:

  1. Devices must meet minimum sensitivity and specificity measures compared with either FDA-cleared nucleic acid-based tests or another FDA-accepted comparator method, or with a correctly performed viral culture method.
  2. Manufacturers must perform annual testing of their devices using currently circulating influenza virus strains and update their product labeling to include test results.
  3. In the event of a declared flu emergency, manufacturers must test characterized samples upon notification by FDA, and promptly report results in the product labeling.