Final Rule on the Use of Ethylene Oxide

The use of Ethlyene Oxide (EtO) in the sterilization of medical devices has been under debate for years, dating back to 2019 when the US Food and Drug Administration (FDA) announced its Innovation Challenges to industry.  Challenge 1 was to identify safe and effective sterilization methods or technologies for medical devices that do not rely […]

Clinical Evaluations and the EU Market

Clinical evaluation is arguably one of the most important topics in the international medical device arena and the EU is no exception. As the EU regulations continue to be rolled out, albeit with a sliding timeline, industry and notified bodies are focusing on the interpretation and implementation of clinical information as it supports the end goal […]

FDA Third Party Review Programs

In August 1996, the FDA launched what was known as the Voluntary Third Party 510(k) Review Pilot Program. The program’s aim was to test out the usage of third parties for performing primary reviews of some medical devices under the 510(k) process in order to improve speed and efficiency. The limitation of the device eligibility was […]

The MHRA Roadmap: Navigating the UK Market

While the European Union (EU) remains hard at work in developing its new regulatory framework for medical devices under the MDR and IVDR, the UK has extended deadlines for the use of currently CE-marked medical devices to be sold in Great Britain (GB) and provided information on transition timelines.  Under this transition: Additionally, self-declared CE-marked […]

FDA Announces the Issuance of Final Rule Amending the Quality System Regulation

Today, the resounding echo of the starting gun reverberates globally, signaling the commencement of a pivotal two-year transition period for device manufacturers and importers. This period marks the urgent need for them to adapt and enhance their quality management systems in alignment with the requirements of the Quality Management System Regulation (QMSR). The long-awaited final rule, issued by the FDA, has been a focal point of anticipation within the medical industry. The call for harmonization between ISO 13485 and the Quality System Regulations (QSRs) has persisted for decades, gaining heightened significance since its formal announcement in 2018 and the subsequent release of the proposed rule in February 2022.

EU Commission proposes another extension for IVDR transition

On January 23rd, amid concerns that there is not enough time for manufacturers to comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR), the EU Commission announced another proposal to extend the transition period.  Previously extended at the end of 2021, this is the second time the Commission will look to provide additional time […]

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’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 […]