What guidance documents on human factors (HF) has FDA released? In May of 2026 the FDA released the guidance document, Content of Human Factors Information in Medical Device Marketing Submissions, which replaced the draft version from 2022. A companion guidance, Applying Human Factors and Usability Engineering to Medical Devices, is referred to as the Human...Read More

Company: Beckman Coulter Inc. Date of Enforcement Report: 8/17/2026 Class: II PRODUCT Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252;...Read More