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The FDA handed Encompas Unlimited a warning letter for failures in quality control, implementation of medical device reporting procedures and incomplete device history records.
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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