Developing Diversity Action Plans within Underrepresented Populations
The FDA’s draft guidance, titled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” outlines the agency’s expectations for sponsors of clinical studies involving drugs, biological products, and devices. The primary goal of this guidance is to enhance the inclusion of underrepresented populations in clinical research, ensuring that study findings […]
Draft Guidance on Use-Related Risk Analysis for Combination Products
In a significant move aimed at enhancing the safety and effectiveness of combination products, the U.S. Food and Drug Administration (FDA) has recently released a draft guidance document focusing on the use-related risk analysis (URRA) for these complex products. This draft guidance represents a crucial step in refining regulatory practices and ensuring that combination products—those […]
CDER Emerging Drug Safety Technology Program
The Emerging Drug Safety Technology Program (EDSTP) is dedicated to the integration of artificial intelligence (AI) and emerging technologies within pharmacovigilance (PV) to advance drug safety and lifecycle management. This program fosters communication with the pharmaceutical industry to enhance the FDA’s understanding of AI-enabled tools and other technologies in PV, aiming to assess their performance, […]
The EU AI ACT: Implications for the Medical Device Industry
The European Union’s recent strides in regulating artificial intelligence (AI) have garnered significant attention, particularly with the introduction of the EU AI Act. This landmark legislation aims to establish a comprehensive regulatory framework for AI systems across various sectors. Among those affected, the medical device industry finds itself at a crucial crossroads, as the implementation […]
ACLA’s Bold Move: Challenging FDA’s Final Rule on LDTs
In a groundbreaking legal maneuver, the American Clinical Laboratory Association (ACLA) has filed the first lawsuit in an attempt to block the implementation of the Food and Drug Administration’s (FDA) Final Rule on Laboratory Developed Tests (LDTs). The contentious Final Rule, which aims to regulate LDTs, has sparked heated debates within the healthcare and regulatory […]
MHRA Launches AI Airlock: Pioneering Innovation in Regulatory Oversight
The Medicines and Healthcare products Regulatory Agency (MHRA) has taken a bold step into the future of regulatory oversight with the launch of the AI Airlock initiative, a new regulatory sandbox designed to help understand risks related to AI as a Medical Device (AIaMD). This groundbreaking endeavor marks a significant leap forward in harnessing the […]
MHRA Proposes Stringent Requirements for High-Risk In Vitro Diagnostic Devices (IVDs)
In a bid to bolster patient safety and enhance regulatory oversight, the Medicines and Healthcare products Regulatory Agency (MHRA) has unveiled proposed requirements for high-risk in vitro diagnostic devices (IVDs) in the United Kingdom. The proposed measures, outlined in a recent consultation document, represent a significant step towards aligning UK regulatory standards with international best […]
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 […]
Upcoming Regulation 2023/607 Transitional Provision Deadlines for MDR
On March 15, 2023, citing the impact of the COVID-19 pandemic, the lack of designated notified bodies and the associated over-capacities, and the imminent threat of significant shortages of necessary medical devices available on the market, the EU set forth Regulation 2023/607, amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for […]
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 […]
