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The FDA flagged device firms in the U.S., Germany, the United Kingdom, the Czech republic, and India for a range of issues, including MDR reports, CAPA failures and other GMP issues. Read More
The International Medical Device Regulators Forum is inviting stakeholder comment on a draft proposal for using real-world data from patient registries in regulatory decisionmaking. Read More
The FDA flagged several U.S. and international facilities for a range of deviations including inadequate complaint procedures, MDR reporting, and recordkeeping. Read More
The International Medical Device Regulators Forum agreed to a new work item proposal to develop technical documents that support a harmonized approach to defining devices manufactured for individual patients. Read More
The Association for the Advancement of Medical Instrumentation released a service-level agreement template to help original equipment manufacturers and healthcare providers improve their working relationships. Read More
The FDA is asking stakeholders for help identifying federal requirements that can be repealed or replaced under the Trump administration’s deregulatory push. Read More
The FDA and Brazil’s National Surveillance Agency have added new auditing bodies to their list of organizations eligible to conduct quality management system audits for the Medical Device Single Audit Program. Read More
The FDA issued warning letters to four device manufacturers for a range of issues, including a failure to seek pre-market approval, to apply for modified intended uses, and quality violations. Read More
Three device manufacturing facilities landed Form 483s from the FDA after inspections turned up numerous problems with their CAPA, complaint, training and MDR procedures. Read More
The FDA issued Form 483s to seven device facilities for a range of deviations including noncompliance with their SOPs and problems with complaints and equipment maintenance. Read More