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.
FDA De Novo classification orders, notices from the EU harmonizing global standards, including an amendment to the ISO 15223-1:2021 standard on device symbols, to the Medical Device and IVD Regulations, and a China NMPA premarket review draft guidance on machine learning-based ECG analysis software are among items captured recently in Pathways’ Document Depot.
