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The FDA is moving ahead with plans for the National Evaluation System for Health Technology (NEST) as one of its top CDRH priorities this year. Read More
The FDA warned device manufacturer Lonza over inadequate validation, CAPA procedures, and other violations at its Walkersville, Md., facility. Read More
International labeling rules requiring the expiration date and date of manufacture on the device label conflict with India’s labeling requirements. Read More