Starting September 24, the Food and Drug Administration will require all Class II devices to be labeled with unique device identifiers. The FDA introduced the unique device identifier system in 2013 ...
Premarket Notification Again Required for Patient and Surgeon's Examination Gloves and Dozens of Class II Devices Proposed for Exemption by Former HHS Secretary JANUARY 15 HHS NOTICE RECONSIDERED BY ...
Sign at the Food and Drug Administrations campus in Silver Spring, MD. Courtesy FDA Government regulation is supposed to make products safer. But new research shows that, at least for medical devices, ...
Once a medical device is brought to market, FDA surveillance of its safety continues. “To facilitate incremental improvements in safety and effectiveness, the FDA allows manufacturers to modify ...
SEATTLE--(BUSINESS WIRE)--Tasso, Inc., the leading provider of convenient, clinical-grade blood collection solutions, today announced that the U.S. Food and Drug Administration (FDA) has cleared its ...
ROSEVILLE, Calif., March 3, 2021 /PRNewswire/ -- InnerScope Hearing Technologies Inc. (OTC: INND) ("InnerScope") announced today it has completed and updated the FDA Medical Device Registration for ...
Please provide your email address to receive an email when new articles are posted on . The FDA has announced a final order to classify the screw sleeve bone fixation device into class II with special ...
After months of speculation and years of debate, the U.S. Food and Drug Administration (FDA) today issued a final regulation classifying dental amalgam and its component parts -- elemental mercury and ...
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