FDA Issues Four Warning Letters to Lab Companies in Less Than Two Months
Laboratory diagnostics manufacturers receive regulatory scrutiny for issues including marketing, quality, and unapproved changes to tests
Laboratory diagnostics manufacturers receive regulatory scrutiny for issues including marketing, quality, and unapproved changes to tests
Whether the MiniDraw™ device dredges up memories of Theranos’ failed tech remains to be seen.
First marketing authorization of a blood test assessing genetic variants related to cancer opens the door for clearance of similar tests.
What lab leaders need to know about the FDA’s three new 510(k) draft guidances.
Lab leaders say that the increased level of scrutiny proposed for such tests would be a detriment to innovation and patient care.
As of October 1, medical device makers must include information about their products’ vulnerabilities when seeking premarket authorization.
More multiplex COVID-19 combination tests emerge from premarket authorization pipeline.
Centers for Medicare & Medicaid Services proposes TCET pathway to expedite Medicare Coverage of newly approved breakthrough devices.
Key approvals announced in June represented important steps forward for the lab testing industry.
So far, it appears many post-PHE COVID-19 tests will be panels for detecting and differentiating among multiple respiratory viruses.
The bill is designed to provide Medicare patients faster access to innovative technology approved by the FDA.