FDA Roundup: April 16, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA’s Center for Devices and Radiological Health (CDRH) announced the unveiling of 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. This dataset of chemicals allows analytical chemistry labs to determine their ability to detect a broad range of potential chemicals. This new dataset is part of CDRH’s ongoing commitment to reduce the burden of premarket processes, while increasing the consistency and transparency of biocompatibility methods. O...