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.
Premarket review guidelines for molecular diagnostics from China, proposed 510(k) exemptions from US FDA, and a new Quality Management System Regulation-aligned compliance program manual from FDA are among items captured recently in Pathways’ Document Depot.