ARTICLE SUMMARY:
Some hot topics were addressed in rules, guides, and consultations last month primarily in Europe and the UK, while US FDA largely sat out policy development efforts, outside of selective editing and deleting of documents, in the opening month of the Trump administration.
Docs of the Month is a regular column highlighting key findings from Pathways’ Document Depot, a database of global medtech regulatory and policy official documents, including rules, guidances, memos, white papers, and more from national authorities, non-governmental groups, and global organizations.
In this edition of Docs of the Month, we spotlight documents with very tangible implications for how device firms develop labels, plan clinical strategy, and make a health economic case for their products, primarily in the EU and UK. At US FDA, meanwhile, many tangible policy development efforts have stalled in the opening weeks of the Trump administration.
