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 In the healthcare sector, older medical devices with outdated or unsupported software present a significant cybersecurity challenge.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PCCP Draft Guidance Released by FDA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 […]
EU Publishes Regulation (EU) 2024/1860 Amid Device Supply Chain Concerns
In response to increasing concerns over supply chain stability and its impact on healthcare delivery, on June 13, 2024 the European Union published Regulation (EU) 2024/1860 of the European Parliament and of the Council which amends both the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to introduce new obligations for companies facing […]
MDCG Revises Guidance on Classification for In Vitro Diagnostics
In a move poised to reshape the regulatory landscape for in vitro diagnostics (IVDs) across Europe, the Medical Device Coordination Group (MDCG) has released new guidance on classification rules. This July 8, 2024 update is the third revision of the guidance and aims to bring clarity and consistency to the classification of IVDs, ensuring that […]
Revised User Fees Guidance on for Combination Products
The U.S. Food and Drug Administration (FDA) has issued its final guidance on user fees for combination products. This new guidance released in July 2024 replaces the previous version from April 2005 and is set to further streamline the regulatory process for combination products. The move is aimed at clarifying the user fee structure and […]
TGA Considering Regulatory Governance of Integrating Assistive Technologies
The Therapeutic Goods Administration (TGA) is reaching out to stakeholders for feedback on a significant initiative that could reshape the landscape of medical technology in Australia. This initiative focuses on incorporating assistive technologies into the existing medical technology (MedTech) framework by treating them as consumer goods, rather than therapeutic goods. Assistive technologies are devices or […]
