Abbott and Roche garnered the lion’s share of new 510(k) lab test approvals in 2022.
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While new test approvals were scarce in October, they were particularly impactful; here are three approvals you should know about.
The agency recently stated that current testing capacity is adequate and established limits on its review of new EUA submissions.
On August 21, the FDA proposed new guidelines on charging for investigational drugs; here are the key highlights.
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.
Now that the finishing touches have been put on LDT-related legislation, what is the likelihood that it will pass?
Senate committee members propose a modified version of legislation allowing the FDA to continue to regulate LDTs on a risk-tiered basis.
InspectIR COVID-19 device detects the virus from breath samples in less than three minutes, offering a new screening option.
The FDA has plans to ensure COVID-19 test makers won’t be left high and dry when the public health emergency ends.
The House Energy and Commerce Committee is considering a pair of rival bills, one Democratic and one Republican, to reform the AA process.