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Not following standard operating procedures (SOP) and lack of key procedures, such as for device master records and labeling products, landed Dentonics a Form 483 after an FDA inspection of its Monroe, N.C., facility. Read More
The FDA needs to revise its Emergency Use Authorization (EUA) policies for tests of future infectious disease outbreaks, the HHS Office of Inspector General recommends in a new report. Read More
The EU’s surveillance system for legacy in vitro devices must remain in place during the transition to the new In Vitro Diagnostic Regulation (IVDR), according to the Medical Device Coordination Group (MDCG) of the European Medicines Agency. Read More
The FDA and the National Institutes of Health have teamed up to fund small businesses that create innovative medical device development tools (MDDT), such as biomarker tests, clinician- and patient-reported outcome measures, nonclinical assessment models and digital health technologies. Read More
The FDA will require electronic submission of 510(k) applications by Oct. 1, 2023, according to a final guidance that provides standards for using the agency’s electronic Submission Template and Resource (eSTAR) portal. Read More