The VALID Act for FDA regulation of laboratory developed tests is working its way through the final stages of the legislative process, but not everyone is loving it.
The agency is once more accepting pre-submissions for all in vitro diagnostic tests, not just those for COVID-19.
Meant to be temporary, remote regulatory assessments proved so successful that the agency will not only continue, but expand their use.
Biotin interference can lead to erroneous lab results in certain IVDs, including some troponin tests.
In a recent report, the GAO says the agency needs a policy when it comes to enforcement discretion regarding tests approved via EUA.