LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
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Articles and Reports
FDA Watch: How Could the Change in US Government Affect IVDs and Labs?
Experts say new leadership could impact the cost and availability of IVDs as well as patients’ ability to afford lab testing
FDA Watch: FDA Moves Slowly on AI-Driven Lab Devices
The agency has approved fewer than 10 tests in the past three years, but a new pipeline of AI-powered products is expected to emerge soon
July 2023 FDA Watch
Key approvals announced in June represented important steps forward for the lab testing industry.
June 2023 FDA Watch
So far, it appears many post-PHE COVID-19 tests will be panels for detecting and differentiating among multiple respiratory viruses.
Bill Would Require Medicare to Cover New Breakthrough Devices for at Least 4 Years
The bill is designed to provide Medicare patients faster access to innovative technology approved by the FDA.
FDA Keeps COVID-19 EUA Pipeline Open While Working toward Transition
HHS secretary takes action to ensure that EUAs remain in effect until the “significant potential” for a COVID-19 PHE no longer exists.
What Happens to COVID-19 Tests after the EUA Pipeline Closes Down?
Companies in the COVID-19 diagnostic products market will need to decide whether to wind down their EUA-based investments.
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.
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.
