ARTICLE SUMMARY:
In this week’s Pathways Picks, the US government shutdown is over and FDA has a full year of funding; the European Commission is preparing reforms to streamline its network of digital and AI laws, as well as the MDR and IVDR; and key guidance documents from the US, South Korea, and China.
Editor’s note: We hope to see you next week at the MedTech Strategist Innovation Summit in San Diego (Nov. 19-21). Due to the conference, our next edition of Pathways Picks will be out a few days later than usual, on Friday, November 21.
US Picks
The longest-ever government shutdown is over, funding FDA, and restarting telehealth payments (updated November 13 to reflect finalized of deal to end the shutdown):
FDA will get full-year funding. FDA is more stable funding ground than many other federal agencies as a result of the agreement to end the longest government shutdown in US history that was signed by the president November 12. Under the deal, FDA, the Departments of Agriculture, Veterans Affairs, and Defense, and some other programs will have appropriations for the entire fiscal year 2026 (through September 30) under the measures, while the rest of the government will only be funded through January 30. FDA, overall, will see a drop in funding compared to FY 2024 levels, down 4.3% to $3.42 billion in congressional budget authority (with a total of $6.96 billion budget including user fees). The agency’s device program, on the other hand, will see a small increase of 1.8% in congressional appropriations compared to FY 2025 (to $454.9 million, not including another $400 million-plus in industry user fees) as requested by the Trump administration to ensure minimum funding triggers are met to allow device user fee collections to continue. Notably, even with the funding rise, the administration has proposed further cuts to FDA staff levels. (See “FDA Proposes Device User Fee Staff Cuts Amid Budget Increase,” Market Pathways, June 10, 2025.)
