2011年 11月 22日
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:
The initial deadline for comments on this issue--September 13, 2011—has now been extended to December 21, 2011.