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…

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…

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. Source: The GMP Letter

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…

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…

The FDA issued warning letters to devicemakers in Michigan, Nevada, Idaho and Texas for numerous quality failures. Source: The GMP Letter

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…

Health Canada issued final guidance for devicemakers on supporting evidence required for submitting applications for 3D-printed implantable devices. Source: The GMP Letter

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. Source: The GMP…

The FDA considers first aid and other “convenience” kits a single device for regulatory purposes, the agency said in final guidance. Source: The GMP Letter