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Blood test to detect colon cancer could move a step closer to FDA approval in the US
CNN via Yahoo News· 7 hours agoGuardant Health’s Shield tests could be the first approved blood screening test for colorectal...
Indica Labs’ HALO AP Dx platform receives FDA 510(k) clearance
Medical Device Network via Yahoo Finance· 16 hours agoHALO AP Dx is compliant with FDA 21 CFR Part 11 and HIPAA regulations, ensuring secure and reliable...
FDA Finalizes Rule and Sets Course to Phase In Oversight of Laboratory Developed Tests | JD Supra
JD Supra· 3 days agoOn May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs), the U.S.
Analysis of sandwich baggie composition raises serious health concerns: 'There is not a safe level'
The Cool Down via Yahoo News· 2 hours agoThe findings raise serious concerns about the safety of these common household items and the...
LDTs: FDA Rolls Out a Phased Implementation for New Regulatory Requirements
The National Law Review· 4 days agoOn May 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final rule significantly...
The Humane Society of the United States and Humane Society Legislative Fund Petition FDA to Revise...
Sierra Sun Times· 5 days agoWASHINGTON — Last week, the Humane Society of the United States and Humane Society Legislative Fund...
FDA Expands Oversight to Laboratory Tests in Hospitals | JD Supra
JD Supra· 2 days agoThe U.S. Food and Drug Administration (FDA) published a final rule amending its regulations to include in vitro diagnostic products (IVDs) as devices, even ...
House Members Question FDA Officials on Lab-Developed Tests, Missed Deadlines
MedPage Today· 2 days agoDevice shortages was one of a number of topics that came up during a wide-ranging hearing featuring ...
No, there isn’t a proposal to ban decaf coffee in the U.S.
WCNC Charlotte· 8 hours agoSeveral recent headlines claim decaf coffee may soon be banned in the United States by the...
FDA Clarifies Distinction Between Device Remanufacturing and Servicing in Final Guidance | JD Supra
JD Supra· 2 days agoThe FDA issued its final guidance document on Remanufacturing of Medical Devices (Final Guidance) on May 10, 2024 to provide clarification on the difference between device ...
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