The FDA has reclassified antigen-based rapid influenza virus antigen detection test systems (RIDTs) from Class I to Class II devices and has introduced special controls aimed at improving the quality of testing.

There is evidence that the currently available antigen-based RIDTs, which are widely used in non-clinical laboratory settings, are performing poorly, resulting in many misdiagnosed cases, the agency said.

 In addition to requiring premarket notification, the final order requires special controls that:

• Identify the minimum acceptable performance criteria;
• Require use of an FDA-accepted comparator method for establishing the performance of new antigen based RIDTs;
• Require annual analytical reactivity testing of contemporary influenza strains; and
• Require analytical reactivity testing of newly emerging strains under certain situations involving an emergency or potential for an emergency.

Manufacturers whose currently legally marketed devices do not meet the minimum performance criteria have one year to submit a 510(k) for a new or significantly changed or modified device.

You have a tangled web of rules, interpretations, issues and actions that make it difficult to know how to proceed when you make a change to one of your medical devices. The Corrections, Removals and Recalls: A Guide for Devicemakers brief sorts it all out for you, defining the key terms and parsing the FDA regulations that govern corrections, removals and recalls.