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Medical Devices / Regulatory Affairs

FDA Lays Out New Guidance on Anthrax Testing Devices

April 2, 2019

The FDA released new guidance for devicemakers hoping to sell equipment to test for anthrax and other dangerous bacteria.

Sponsors must include detailed descriptions for how the devices should be used, the chemicals involved in the tests, how to test the devices how specimens should be stored and how the device should be shipped and how to interpret and report test results, the agency says.

The companies must also include a statement that says, “The interpretation of test results requires experienced clinical personnel who have training in principles and use of microbiological culture identification methods and infectious disease diagnostics and have the necessary awareness to report an identification of B. anthracis and coordinate with local or state public health directors.”

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