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The FDA posted a series of frequently asked questions (FAQ) Thursday about the use “legacy” identification numbers for medical devices as the agency shifts to the Unique Device Identification (UDI) system. Read More
Cybersecurity doesn’t just apply to the products you are building today, it applies to legacy products still in use many years after installation — and devicemakers need to install post marketing updates that either bring these older devices up to today’s standards, or make them obsolete, advised one device security expert at the WCG-FDAnews Annual Inspections Summit in Washington, D.C., on Thursday. Read More
Johnson & Johnson (J&J) and its subsidiary Ethicon are seeking a review by the U.S. Supreme Court (SCOTUS) of the $302 million in imposed on them for misrepresenting the risk of their pelvic mesh products in marketing materials, arguing their due process rights were violated. Read More
The approval was based on a clinical trial in which about 35 percent of the 106 enrolled ovarian cancer patients were positive for the marker, as determined by the assay. Read More
Cybersecurity relates closely to both design controls and risk management in the medical device arena. So, any efforts to address cybersecurity must be incorporated into existing design and development planning, as well as overall risk management practices. That means that companies cannot simply stick an authentication algorithm or other Band-Aid on their connected device and be in compliance with regulations. Read More
DeVilbiss Healthcare received a Form 483 from the FDA for inadequate complaint handling, design verification and lack of corrective and preventive action (CAPA) procedures, following an Aug. 1-17 inspection of its Somerset, Pa., facility. Read More