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.