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 […]
Cybersecurity Awareness Month: Addressing the Legacy Device Dilemma in Healthcare
October is recognized as Cybersecurity Awareness Month, highlighting the importance of safeguarding sensitive data and systems from cyber threats. In the healthcare sector, older medical devices with outdated or unsupported software present a significant cybersecurity challenge. These legacy devices, found in hospitals across the U.S., expose facilities to potential cyberattacks, particularly as many of these […]
Electronic Submissions of De Novo Applications Required in 2025
Starting October 2025, the U.S. Food and Drug Administration (FDA) will require all De Novo classification requests to be submitted electronically, via the electronic Submission Resource and Resource (eSTAR) template, marking a significant shift in regulatory submission processes for medical devices. This transition aims to streamline the approval process and enhance the efficiency of device […]
PCCP Draft Guidance Released by FDA
The U.S. Food and Drug Administration (FDA) has officially released its highly anticipated guidance on Pre-Determined Change Control Plans (PCCPs)for medical devices. This new framework is set to streamline regulatory processes and enhance flexibility for device manufacturers, offering a structured approach to managing modifications to approved devices. PCCPs represent a significant shift in how manufacturers […]
TGA Seeks to Align Essential Principles with EU Regulations
In a bid to harmonize regulatory practices and streamline the approval process for medical technologies, the Therapeutic Goods Administration (TGA) has initiated a consultation to align Australian Essential Principles with European Union (EU) Regulations’ General Safety and Performance Requirements (GSPR). This move marks a significant step toward improving market access, ensuring safety, and fostering innovation […]
EMA Launches a Pilot Program on Orphan Medical Devices
In a significant move to address a critical gap in the healthcare industry, a new pilot program has been launched to support orphan medical devices. On August 2, 2024, the European Medicines Agency (EMA) announced that its effort, as mandated under Regulation (EU) 2022/123 (Regulation – 2022/123 – EN – EUR-Lex (europa.eu)), aims to provide […]
Guiding Principles on Transparency for Machine Learning Medical Devices
In a significant move toward enhancing the safety and efficacy of machine learning-enabled medical devices (MLMDs), regulatory bodies from the United States, Canada, and the United Kingdom have jointly released new guiding principles focused on transparency throughout the life cycle of MLMDs. The U.S. Food and Drug Administration (FDA), Health Canada, and the UK’s Medicines and […]
