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BD supports higher flu test standards from FDA

FDA proposes to raise flu testing device classification to require higher detection rates

FRANKLIN LAKES, N.J. — At least one company making rapid influenza tests agrees with proposed new standards from the Food and Drug Administration.

BD said Monday that it would support the FDA's proposal to reclassify rapid influenza tests as Class II devices. They are currently considered Class I, and the new classification would hold them to higher performance standards in order to give healthcare providers criteria for evaluating the tests they use.

The proposal would increase performance requirements for the tests to attain a sensitivity of at least 90% for influenza A and 80% for influenza B; any test not meeting those requirements would have to be withdrawn form the market one year after the rule is finalized. BD makes the Veritor System Flu A+B Test, which it launched two years ago.

"This proposal is a step in the right direction as physicians and hospitals routinely rely on rapid diagnostic influenza tests to help manage patients that are suspected of having influenza," BD Diagnostics president for diagnostic systems Tom Polen said. "Raising the standards of rapid influenza tests will provide healthcare providers the right information to guide patient diagnosis and treatment without requiring repeat testing."

 

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