CDRH Unveils New Dataset to Help Improve Chemical Characterization Methods for Biocompatibility of Medical Devices
FDA’s Center for Devices and Radiological Health (CDRH) is unveiling a new public dataset designed to help assist chemistry labs in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices. The Chemicals List for Analytical Performance (CLAP) tool is chemical dataset intended to help analytical laboratories demonstrate their ability […]
FDA Launches Health Care at Home Initiative to Help Advance Health Equity
U.S. Food and Drug Administration announced the launch of a new initiative, Home as a Health Care Hub, to help reimagine the home environment as an integral part of the health care system, with the goal of advancing health equity for all people in the U.S. The FDA’s Center for Devices and Radiological Health (CDRH) […]
CDRH Issues 2024 Safety and Innovation Reports
The FDA’s Center for Devices and Radiological Health (CDRH) announced the release of its 2024 safety and innovation reports, which underscore the Center’s proactive measures in updating the 2018 Medical Device Safety Action Plan and regulating the advancements in technology while fostering a more innovative landscape for device manufacturers in the United States. The CDRH […]
Navigating the EU Clinical Trials Regulation (CTR)
The European Union Clinical Trials Regulation (EU CTR) represents a landmark shift in the regulation of clinical research within the EU. Enacted to streamline and harmonize the conduct of clinical trials across member states, the CTR aims to enhance patient safety, promote transparency, and facilitate the timely initiation and completion of clinical research. As the […]
The EU IVDR Impact on Clinical Trials
The European Union In Vitro Diagnostic Regulation (EU IVDR) stands as a pivotal framework shaping the landscape of medical device regulation within the EU. While primarily targeting in vitro diagnostic (IVD) devices, its ramifications extend beyond mere device certification. Among its ripple effects lies a significant impact on clinical trials, particularly those involving IVDs. Understanding […]
ANVISA’s Recognition of Decisions by International Regulators: Facilitating Access to Medical Devices in Brazil
In the realm of healthcare, access to safe and effective medical devices is paramount to ensuring quality patient care. Brazil, as one of the largest healthcare markets in the world, has been taking significant strides to streamline its regulatory processes and facilitate the entry of medical devices that have been approved by reputable international regulatory […]
Select Updates for the Premarket Cybersecurity Guidance: What You Need to Know
FDA is proposing to selectively update the final guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.”
FDA Whitepaper: Artificial Intelligence & Medical Products – What You Need to Know
Artificial intelligence (AI) holds immense potential to revolutionize healthcare, offering advancements in medical product development, improving patient care, and augmenting the capabilities of health care practitioners. With a shared commitment toward fostering innovation and upholding quality, safety, and effectiveness, FDA plans to align their efforts to advance the responsible use of AI for medical products. […]
Guidelines Updated on Phthalates
Phthalates are a group of chemicals commonly used as plasticizers to make plastics more flexible, durable, and transparent. Recently, the EU Commission requested the first update from SCHEER since 2019, to which SCHEER has responded by providing information as to how the manufacturing community has evaluated potential alternatives to the use of phthalates and how this will impact both the design and use of their products.
Final Rule on the Use of Ethylene Oxide
The use of Ethlyene Oxide (EtO) in the sterilization of medical devices has been under debate for years, dating back to 2019 when the US Food and Drug Administration (FDA) announced its Innovation Challenges to industry. Challenge 1 was to identify safe and effective sterilization methods or technologies for medical devices that do not rely […]
