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FDA Roundup: May 10, 2024
FOX 16 Little Rock· 1 day agoOn Thursday, the FDA provided information on how to safely charge hearing aids, glucose monitors, insulin pumps, and other medical devices to avoid overheating. Medical devices ...
FDA recalls faulty iOS app that injured hundreds of insulin pump users
TechSpot· 15 hours agoThe big picture: The recall underscores the FDA's challenge in keeping pace with innovation in healthcare technology. While criticisms regarding the agency's slow processes ...
FDA issues recall statement on insulin pump app after glitch causes more than 200 injuries
USA Today· 2 days agoThis is a Class 1 recall, which the FDA says is the most serious type of recall, and use of the...
FDA Issues Final Rule to Regulate Laboratory-Developed Tests as Medical Devices
The National Law Review· 2 days agoOn May 6, 2024, the U.S. Food and Drug Administration published its anticipated final rule...
Unpacking Averages: Assessing the Products Included in FDA's Voluntary Malfunction Summary Reporting...
The National Law Review· 4 days agoAt the end of 2022, FDA published a draft guidance on Voluntary Malfunction Summary Reporting (VMSR)...
FDA’s Final LDT Rule Is Here, and the Changes Show the Agency Is Serious and Actually Listening to...
The National Law Review· 6 days agoThe Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs)...
FDA Finalizes Rule Regulating Laboratory Developed Tests
The National Law Review· 6 days agoFDA’s Final Rule regulating Laboratory-Developed Tests (LDTs) has been published in the Federal...
FDA considers updating blood donation guidelines to keep nation’s supply safe from malaria
WKBT La Crosse· 2 days agoAs late as the 1940s, the US Centers for Disease Control and Prevention said Thursday in a...
FDA Experts Weigh In On Incannex's CannQuit-O With Feedback On CBD As Treatment For Opioid Use...
Benzinga· 5 days agoHealthcare Inc. IXHL, a cannabinoid and psychedelic medicine biotechnology company, announced the...
FDA Finalizes Rule to Assert Authority Over Laboratory Developed Tests | JD Supra
JD Supra· 6 days agoThe Food and Drug Administration (FDA) published its long-awaited Final Rule that will regulate laboratory developed tests (LDTs) as in vitro diagnostic (IVD) medical devices ...
