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The FDA announced Friday that remote regulatory assessments (RRA) have proven to be a valuable tool and the agency will continue to use them beyond the COVID-19 pandemic. Read More
In a final guidance released on Friday, the FDA said it will enforce standard date formatting and Unique Device Identification (UDI) labeling requirements for certain class I and unclassified devices starting on Dec. 8. Read More
QuadM Technologies received a Form 483 from the FDA after an inspection of its Hamilton, N.J., facility in April that highlighted a variety of documentation issues. Read More
Failure to ensure that its medical devices met regulatory and other requirements landed Health Care Technology (HCT) a Form 483 from the FDA following an inspection at its Ashland, Mass. facility in April. Read More
The Department of Justice (DOJ) has launched a nationwide law enforcement action against fraudulent billing for cardiovascular and cancer genetic tests and medical devices. Read More
The FDA has granted Breakthrough Device designation to Roche’s Elecsys Amyloid Plasma Panel, a minimally invasive test for early diagnosis of Alzheimer’s through blood biomarkers, which could become the first FDA-approved test for this disease. Read More