Regulatory Science Tools Catalog

On May 13, 2024, FDA’s Office of Science and Engineering Laboratories (OSEL) launched an improved online Regulatory Science Tool (RST) Catalog to enhance search and browse capability as well as allow for long-term growth in published tools. The RST Catalog is now organized by research program and device type, cross referenced by both program and RST category, […]

FDA Issues Remanufacturing Guidance

On May 10, 2024, the FDA issued a guidance document on “Remanufacturing of Medical Devices.” Remanufacturing is the processing, conditioning, renovating, repackaging, restoring, or any other act done to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use. The document is intended help clarify whether activities performed on […]

FDA Issues Final Rule on Laboratory Developed Tests

the FDA clarified that In vitro Diagnostic Devices (IVDs), including Laboratory Developed Tests (LDTs), are regulated as devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), even when manufactured by laboratories. This move aims to enhance patient safety by phasing out enforcement discretion for most LDTs over four years, aligning requirements for IVDs regardless of where they are made.

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 […]

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. […]

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 […]