FDA Watch: CDRH Budget May Not See Steep Cuts in FY 2026
A leaked budget document for the next fiscal year suggested non-user fee funding may be up slightly compared to recent years.
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Articles and Reports
Next Steps: With LDT Final Rule Now Null, Industry Groups Urge Lab Managers and Pathologists to Advocate for Change
CAP and AMP officials weigh in on plans to push for a legislative- or CLIA-based approach to future LDT oversight
LDT Appeal: Looking at the Legal Nuances Behind Potential FDA Actions Following Court Decision
Marginal LDT scenarios could be where the FDA focuses on next, a lawyer notes
FDA Watch: What Labs Need to Know About New Medical Device Cybersecurity Rules
As of October 1, medical device makers must include information about their products’ vulnerabilities when seeking premarket authorization.
September 2023 FDA Watch
More multiplex COVID-19 combination tests emerge from premarket authorization pipeline.
August 2023 FDA Watch
Centers for Medicare & Medicaid Services proposes TCET pathway to expedite Medicare Coverage of newly approved breakthrough devices.
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.
