ARTICLE SUMMARY:
A sortable and searchable running inventory of global medtech regulatory and policy official documents, including rules, guidance documents, memos, white papers, and more from national authorities, non-governmental groups, and global organizations.
Draft FDA guidance on upcoming quality management expectations in premarket submissions, guidance from South Korea on evaluating unexpected adverse events in device trials, and a year-one report from the UK’s Regulatory Innovation Office are among items captured recently in Pathways’ Document Depot.
