FDA Reopens Comment Period for Microbiology/Medical Countermeasure Device Evaluations

The US Food and Drug Administration is seeking further comment on its proposed approach for evaluating highly multiplexed microbiology and medical countermeasure diagnostic devices.

The agency’s request follows a public meeting in mid October covering performance evaluations of these devices. Now, the FDA is seeking additional feedback on a concept paper on its proposed evaluation plans for these devices, “Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices.”

Specific areas of focus include:

  • Clinical application of highly multiplexed microbiology devices, as well as public health and clinical needs
  • Device evaluation, including methods to evaluate clinical and analytical performance of highly multiplexed microbiology devices, as well as validation methods when positive specimens are not readily available
  • Reference databases, including quality criteria for establishing accuracy and methods for setting up and maintaining databases

The initial deadline for comments on this issue--September 13, 2011—has now been extended to December 21, 2011.

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