Effective January 2018, the FDA is reclassifying rapid influenza antigen detection tests. Here’s what you need to know about this reclassification.
|The Food and Drug Administration (FDA) has announced the reclassification of rapid influenza antigen detection tests. Tests that do not meet these new standards will not be available for purchase after January 12, 2018.|
|The FDA requirement, announced on January 12, 2017, mandates that Visually Read Rapid Flu Tests must now adhere to new, higher performance standards.|
|The FDA is reclassifying antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation.|
|No new CPT code is anticipated as part of this reclassification.|
Who’s affected by this flu reclassification regulation?
Any healthcare setting running select rapid influenza antigen detection tests (RICTs) which do not meet the new standards set by the FDA may be affected, including:
Physician Offices • Medical Practices • Pediatric Offices • Community Health Centers •
Urgent Care Centers • Health Systems
Key Dates for the 2018 Flu Reclassification
January 12, 2017
The FDA published the final reclassification ruling
January 12, 2018
Per the FDA ruling, tests that fail to meet the new standards cannot be marketed, sold or distributed after this date. Please note: Affected products purchased prior to January 12, 2018 may still be used until their expiration date
Why is this flu reclassification happening?
- Influenza diagnostics currently regulated as Class I do not meet the needs of patients, physicians or the public health
- Reclassification to Class II will allow for Special Controls to be applied to RIDTs
- The ruling establishes and maintains minimum performance criteria for RIDTs throughout their product lifecycle
“The AAP finds the FDA proposal to reclassify influenza virus antigen detection systems from Class I devices to Class II devices to be much needed and appropriately written […] RIDTs have proven to be inaccurate […] Pediatricians are concerned that these devices are giving false positives or negatives on the children on whom these tests are used…without treatment the infection could worsen and subsequent negative consequences could occur. It is crucial for the treatment and health of children that these tests are safe, accurate and effective.” – American Academy of Pediatrics
How should you prepare for the flu reclassification regulation?
Act now to meet FDA flu testing reclassification.
- If you purchased Visually Read Rapid Flu Tests before January 12, 2018, determine if they meet the reclassification criteria
- If your Visually Read Rapid Flu Tests do not meet reclassification criteria, you can continue to use them until their expiration date, as normal, but the product cannot be returned
- Develop a Flu Reclassification Transition Plan to shift to new products that meet these new standards, onboard these products and train your staff
- Explore options to move to a reader or a molecular device. These devices can:
- Help provide improved workflows and clinical testing accuracy
- Eliminate the subjectivity of visually read test results
- Offer accurate test results at the point of care, leading to faster time to diagnose and treat, and increased antibiotic stewardship
- Molecular testing can also provide better reimbursements (depending on your state)
Additional resources for healthcare providers
For more details about this reclassification, visit the FDA Federal Register on the Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical Specimens.