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The FDA issued final guidance on the information devicemakers should include in test report summaries, test protocols and complete test reports for non-clinical bench performance testing for premarket submissions. Read More
Health Canada is increasing fees for device sponsors and will peg ongoing increases to inflation, the agency said in a final report on the planned changes. Read More
Washington Democratic Sen. Patty Murray is demanding answers from the leaders of three device companies at the center of an ongoing FDA investigation of contaminated duodenoscopes that regulators worry are spreading deadly bugs. Read More
The FDA issued an alert over a recall of Beckman Coulter DxH 800, DxH 600 and DxH 900 blood analyzers, updating an urgent medical device correction letter the company issued following complaints of inaccurate blood platelet counts. Read More
Phototherapy developer National Biological Corp. fell short on several quality management systems, the FDA said following a Feb. 4-14 inspection of its Beachwood, Ohio plant. Read More
Failure to establish standard operating procedures for investigations landed Singapore-based diagnostics maker MP Biomedicals Asia Pacific in hot water with the FDA following a Dec. 10-12, 2018 inspection of its Singapore facility. Read More
Process validation issues and failure to document complaints and corrective and preventive actions landed devicemaker Duke Empirical an FDA Form 483 following a Dec. 3-21, 2018, inspection of its Santa Cruz, California plant. Read More
The European Commission released new details on what datasets devicemakers should include in the Eudamed database for unique device identifiers under the new Medical Device Regulation and In Vitro Diagnostic Regulation. Read More
Health Canada issued final guidance for devicemakers on supporting evidence required for submitting applications for 3D-printed implantable devices. Read More
The FDA has finalized a list of accessories that can be classified as Class 1 devices. The listing was required under the FDA Reauthorization Act of 2017. Read More