Definitive MDSAP Program Update Webinar

Definitive mdsap program update webinar Simplify the intricacies of MDSAP with actionable insights and expert guidance.  Watch this previously recorded webinar, “Definitive MDSAP Program Update: Strategies for Global Compliance & Market Success,” presented by MedTech Leading Voice. Here’s a glimpse at what to expect: Actionable tips to ensure a smooth MDSAP certification and audit process. […]

Accelerating Clinical Trials in the EU: Two Pilots Go Live

Clinical trials are the cornerstone of medical innovation, driving the development of new treatments and therapies that improve patient outcomes and advance healthcare. However, the traditional clinical trial process is often lengthy and complex, posing significant challenges for researchers, sponsors, and patients alike. The COVID-19 era brought a decrease in multi-state clinical trials applications in […]

Regulatory Science Tools Catalog

On May 13, 2024, FDA’s Office of Science and Engineering Laboratories (OSEL) launched an improved online Regulatory Science Tool (RST) Catalog to enhance search and browse capability as well as allow for long-term growth in published tools. The RST Catalog is now organized by research program and device type, cross referenced by both program and RST category, […]

FDA Issues Remanufacturing Guidance

On May 10, 2024, the FDA issued a guidance document on “Remanufacturing of Medical Devices.” Remanufacturing is the processing, conditioning, renovating, repackaging, restoring, or any other act done to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use. The document is intended help clarify whether activities performed on […]

FDA Issues Final Rule on Laboratory Developed Tests

the FDA clarified that In vitro Diagnostic Devices (IVDs), including Laboratory Developed Tests (LDTs), are regulated as devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), even when manufactured by laboratories. This move aims to enhance patient safety by phasing out enforcement discretion for most LDTs over four years, aligning requirements for IVDs regardless of where they are made.

CDRH Unveils New Dataset to Help Improve Chemical Characterization Methods for Biocompatibility of Medical Devices

FDA’s Center for Devices and Radiological Health (CDRH) is unveiling a new public dataset designed to help assist chemistry labs in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices. The Chemicals List for Analytical Performance (CLAP) tool is chemical dataset intended to help analytical laboratories demonstrate their ability […]

FDA Launches Health Care at Home Initiative to Help Advance Health Equity

U.S. Food and Drug Administration announced the launch of a new initiative, Home as a Health Care Hub, to help reimagine the home environment as an integral part of the health care system, with the goal of advancing health equity for all people in the U.S. The FDA’s Center for Devices and Radiological Health (CDRH) […]

CDRH Issues 2024 Safety and Innovation Reports

The FDA’s Center for Devices and Radiological Health (CDRH) announced the release of its 2024 safety and innovation reports, which underscore the Center’s proactive measures in updating the 2018 Medical Device Safety Action Plan and regulating the advancements in technology while fostering a more innovative landscape for device manufacturers in the United States.  The CDRH […]

Navigating the EU Clinical Trials Regulation (CTR)

The European Union Clinical Trials Regulation (EU CTR) represents a landmark shift in the regulation of clinical research within the EU. Enacted to streamline and harmonize the conduct of clinical trials across member states, the CTR aims to enhance patient safety, promote transparency, and facilitate the timely initiation and completion of clinical research. As the […]

The EU IVDR Impact on Clinical Trials

The European Union In Vitro Diagnostic Regulation (EU IVDR) stands as a pivotal framework shaping the landscape of medical device regulation within the EU. While primarily targeting in vitro diagnostic (IVD) devices, its ramifications extend beyond mere device certification. Among its ripple effects lies a significant impact on clinical trials, particularly those involving IVDs. Understanding […]