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Devicemakers can improve their facility inspection experience by engaging in constructive conversations with agency investigators, an FDA official says. Read More
Swiss and Chinese regulators plan to harmonize their regulations on market authorization and postmarket surveillance, with the aim of speeding access to new products in both markets. Read More
The FDA has warned Craftmatic Industries over inadequate complaint handling and manufacturing procedures for its Adjustable Home-Use Therapeutic Bed. Read More
Life Technologies, a manufacturer of biomedical products, was handed a Form 483 for failing to submit timely MDRs after erroneous results from some of its tissue-typing kits. Read More
Device failures and inadequate complaint handling procedures resulted in a Form 483 for Biogenex Laboratories, a maker of automated molecular pathology workstations. Read More
The FDA handed U.S. Infusion a Form 483 for violations including failure to notify the agency within 30 days after learning of a device malfunction that could result in patient injury or death. Read More
U.S. FDA officials visiting India laid out a new approach to facility inspections that would reward Indian devicemakers whose quality management systems exceed the minimum. Read More
The number of medical devices recalled in the U.S. during the final quarter of 2014 increased over the previous quarter despite an overall drop in the number of recall actions, a report from Stericycle Expert Solutions shows. Read More
Indian devicemakers, together with governmental and nongovernmental partners, have formed a steering committee to push a self-certification proposal for manufacturing best practices. The aim is to ensure the quality of Indian devices and eliminate sales of substandard products. Read More