The Global Regulatory Landscape for AI/ML-Enabled Medical Devices
As artificial intelligence (AI) and machine learning (ML) technologies rapidly evolve, their integration into medical devices is transforming healthcare. From diagnostic tools to treatment algorithms, AI/ML-enabled devices offer significant benefits but also pose unique regulatory challenges. Technology in medical device applications is shifting and digital health is becoming more a part of every-day healthcare, through […]
The Impact of Augmented Reality and Virtual Reality on Medical Devices
In recent years, Augmented Reality (AR) and Virtual Reality (VR) have emerged as transformative technologies across various sectors, and healthcare is no exception. Their integration into medical devices is revolutionizing everything from surgical procedures to patient education. It’s important to understand how AR and VR are impacting medical devices, enhancing healthcare delivery, and improving patient […]
The Status of Use-Related Risk Analysis
Recently, a coalition of industry groups has made a strong call for revisions to the U.S. Food and Drug Administration’s (FDA) guidance on use-related risk analyses (URRA). This plea for change underscores growing concerns about the practical implications of the current guidelines and their impact on the development and approval of medical devices. The Current […]
US Regulation of Ingestible Medical Devices
Ingestible medical devices are at the forefront of innovation in healthcare, offering unique solutions for monitoring patient health and delivering therapies. These devices, which can be swallowed and often operate within the gastrointestinal tract, range from capsule endoscopes to drug delivery systems. As their use expands, understanding the regulatory framework governing these technologies in the […]
Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
The FDA has released final guidance titled “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers.” This document offers updated recommendations for sponsors, clinical investigators, institutional review boards, contract research organizations, and other stakeholders on using electronic systems, records, and signatures in clinical trials involving foods, medical products, tobacco products, and […]
