MDCG UPDATES Q&A ON IMPORTERS AND DISTRIBUTORS
The Medical Device Coordination Group (MDCG), the regulatory body that works toward ensuring the safe and effective use of medical devices in Europe, recently updated a Q&A document on how both the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) apply to importers and distributors. Under both regulations, an economic operator is defined […]
Decentralized Clinical Trials: A Clinical Trial Optimization Opportunity
Recent trends in clinical studies, including the nearly ubiquitous move to electronic data capture (EDC) systems across CROs/sponsors and electronic medical records (EMR) systems amongst hospital systems/private practices, has provided a fertile environment in which to institute decentralized clinical trials (DCTs). The additional factor of the COVID-19 global pandemic ushered in a need to explore […]
FDA Changes Guidance on the Use of ISO 10993-1:2016
ISO 10993-1 is recognized as the gold standard when it comes to the selection of applicable biological testing of medical devices and the associated risk assessment, while also providing valuable information pertaining to the potential need for additional testing based on available data. In 2020, the FDA updated the guidance document ‘Use of International Standard […]
FDA’S LABORATORY DEVELOPED TESTS ENFORCEMENT RULE
Laboratory developed tests (LDTs) are in vitro diagnostic devices (IVDs) for use in clinical settings and play a vital role in the health industry. LDTs are still regulated by the federal government, via the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) under the Public Health Service Act. Laboratories […]
