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
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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
FDA Watch: AI-Based Sepsis Prediction Test Receives FDA Authorization
Prenosis claims its test can detect the presence of the often deadly condition within 24 hours of a hospitalization
FDA Watch: Gottlieb Resignation Costs Lab Industry a Valuable Frenemy
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FDA Watch: Agency Finalizes New Medical Device Marketing Pathway & Okays Direct Lab Reporting of PGx Test Results
From - Laboratory Industry Report
On Jan. 22, the FDA issued final guidance establishing a new alternative pathway for getting medical devices to…
FDA Watch: Agency Floats Plan to Simplify 510(k) Premarket Review
From - Laboratory Industry Report
Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including…
FDA Watch: First NGS Residual Cancer Detection Test Wins Approval
From - Laboratory Industry Report
The FDA broke new ground by allowing marketing of Adaptive Biotechnologies' ClonoSEQ assay, a next generation sequencing (NGS)-based test for…
FDA Watch: Changes to CBER Email Policy May Affect Your Lab
From - Laboratory Industry Report
Heads up to any lab that's subject to oversight by the CBER, i.e., the FDA agency responsible for regulating biological products for human use…
FDA Watch: New LDT Proposal Is Much Different from One Negotiated with Industry
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FDA Watch: Lab Industry Objects to Agency’s New LDT Proposal
From - Laboratory Industry Report
On Aug. 3, the Food and Drug Administration heated the long simmering controversy over FDA regulation of laboratory developed tests (LDTs) to full boil by submitting…
FDA Watch: Agency Confirms that LOINC Coding of IVD Tests Is Voluntary
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FDA Watch: Agency Offers a Modicum of Relief on DTC Marketing of Genetic Tests
From - Laboratory Industry Report
Last November, the FDA raised eyebrows with a notice for public comment proposing to make it easier to bring new…
FDA Watch: Why the New NGS Guidance May Be a Paper Tiger
From - Laboratory Industry Report
Last month, the FDA finalized a pair of guidance documents designed to liberalize and speed up approval of new next-generation sequencing…