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 […]
EMA’s New Guideline on Therapeutic Equivalence in Nasal Products
The European Medicines Agency (EMA) is poised to introduce a new guideline aimed at establishing more robust comparative data to support therapeutic equivalence (TE) for nasal products to address gaps in the current framework. Therapeutic equivalence refers to the concept where two drugs or drug products are considered interchangeable if they are expected to have […]
Guidance for Essential Drug Delivery Outputs for Devices
The draft guidance document titled “Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products” released by the FDA in June 2024 provides industry stakeholders with key recommendations on essential drug delivery outputs (EDDOs) for drug delivery devices and combination products. EDDOs are critical to the design process and essential in ensuring […]
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 […]
Regulatory Strategy & 510(k) Submission Support
CHALLENGE: A new US based division manufacturer of a Chinese dental implant, wanted to grow their business by bringing their product, material used in the construction of dental implants, to the US market. With no prior experience in US medical device regulations, they needed assistance determining the best regulatory path and guidance to navigate the […]
WHO Launches the Medical Devices Information System
In a significant stride towards enhancing global healthcare standards, the World Health Organization (WHO) has unveiled a pioneering online platform named MeDevIS (Medical Devices Information System). This platform, which went live on July 8, 2024, marks a crucial advancement in the realm of medical devices, aiming to streamline information dissemination, improve regulatory processes, and ultimately […]
