FDA Watch: 2022 510(k) Lab Test Approvals Year in Review
Abbott and Roche garnered the lion’s share of new 510(k) lab test approvals in 2022.
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The Top 10 Most Significant FDA New Lab Test Approvals of 2022
Here are what G2 Intelligence considers to be the 10 most significant FDA lab testing clearances of 2022, in rough chronological order.
December 2022 FDA Watch: More Approvals in US than EU
A high volume of FDA approvals for new tests and diagnostic products made up for the relatively low number of approvals in the EU.
FDA Watch: Monkeypox, COVID-19, and MDD Tests
While new test approvals were scarce in October, they were particularly impactful; here are three approvals you should know about.
FDA Sets New Limits on EUA Requests for COVID-19 Tests
The agency recently stated that current testing capacity is adequate and established limits on its review of new EUA submissions.
FDA Watch: New Guidance on Charging for Investigational Drugs
On August 21, the FDA proposed new guidelines on charging for investigational drugs; here are the key highlights.
FDA Re-Opens Pre-Submission Requests for Non-COVID-19 IVD Tests
The agency is once more accepting pre-submissions for all in vitro diagnostic tests, not just those for COVID-19.
FDA to Continue Remote Regulatory Assessments after Pandemic Ends
Meant to be temporary, remote regulatory assessments proved so successful that the agency will not only continue, but expand their use.
Bill to Regulate LDTs Advances, but Is No Slam Dunk for Final Passage
Now that the finishing touches have been put on LDT-related legislation, what is the likelihood that it will pass?
New VALID Act Would Establish Risk-Based System for LDTs Regulation
Senate committee members propose a modified version of legislation allowing the FDA to continue to regulate LDTs on a risk-tiered basis.
FDA Issues First Approval for SARS-CoV-2 Breathalyzer Test
InspectIR COVID-19 device detects the virus from breath samples in less than three minutes, offering a new screening option.
EUA COVID-19 Tests to Remain on US Market After PHE Expires
The FDA has plans to ensure COVID-19 test makers won’t be left high and dry when the public health emergency ends.
Congress Looks to Beef up Agency’s Power to Withdraw Unproven AA Drugs
The House Energy and Commerce Committee is considering a pair of rival bills, one Democratic and one Republican, to reform the AA process.
