The U.S. International Trade Commission (USITC) says it will investigate patent infringement/trade violations for certain intravascular administration sets and components, based on a March 13 complaint. Read More
Despite the failure of the American Health Care Act, which included a provision to repeal the 2.3% device tax introduced under the Affordable Care Act, AdvaMed President and CEO Scott Whitaker said he’s confident Congress will find anoth... Read More
The FDA has issued a warning letter to Abbott citing serious CAPA and other violations at its St. Jude Medical defibrillator manufacturing facility in Sylmar, Calif. Read More
The International Medical Device Regulators Forum has released final guidance on harmonized terminology for reporting adverse events related to medical devices and IVDs. Read More
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