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FDA flu reclassification

Published Date
AuthorVal DuVernet

As of January 2018, the FDA reclassified rapid influenza antigen detection tests. Here’s what you need to know about this reclassification.

What happened?

  • 美国食品和药物管理局(FDA) announced the reclassification of rapid influenza antigen detection tests. Tests that do not meet these new standards are no longer available for purchase as of 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 has reclassified antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that were 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 was anticipated as part of this reclassification

Who was 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 and health systems.

Key dates for the 2018 flu reclassification

January 12, 2017
The FDA published the final reclassification ruling

January 12, 2018
/ FDA裁决,测试,未能满足东北w standards can no longer be marketed, sold or distributed after this date.

Why did this flu reclassification happen?

  • Influenza diagnostics regulated as Class I did not meet the needs of patients, physicians or the public health

  • Reclassification to Class II allows 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