Remote Regulatory Assessments: What You Need To Know
Travel restrictions, brought on during the COVID-19 pandemic, forced the US Food and Drug Administration (FDA) to adapt its mode of operations with respect to field inspections by employing a remote regulatory assessments (RRA) strategy. FDA used these RRAs to ensure continuity of inspections for compliance with applicable FDA requirements where an on-site presence was not […]
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 […]
FDA ESTABLISHES A NEW DIGITAL HEALTH ADVISORY COMMITTEE
The world of technology is moving at lighting speed. We are experiencing advances in software capabilities, interactions with automated services, and a far greater emphasis on how we are becoming more reliant on digital processes in our everyday lives. Case in point, when was the last time you were able to actually talk to a […]
FDA UPDATE: FINAL GUIDANCE SUBMISSION AND REVIEW OF STERILITY INFORMATION IN PREMARKET NOTIFICATION (510(K)) SUBMISSIONS FOR DEVICES LABELED AS STERILE
On Jan. 8, 2024, the FDA updated the final guidance on “Submission and Review of Sterility Information in 510(k) Submissions for Devices Labeled as Sterile”. Within the document, the FDA announces that it has recategorized vaporized hydrogen peroxide (VHP) to be an Established Category A sterilization process. As such, this places VHP in the same […]
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 […]
