ARTICLE SUMMARY:
In this week’s Pathways Picks: FDA can’t accept new premarket submissions as a shutdown of the US federal government takes hold; the Department of Commerce launches an investigation into device imports that could lead to more tariffs; CDRH publishes FY 2026 guidance priorities; AI updates from the US, UK, and Europe; outputs from the recent IMDRF meeting of global regulators; and more from Europe, China, and the US.
Editor’s note: A new Pathways Picks will not publish on October 8 —look for the next edition on October 15. The Market Pathways editorial team will be attending The MedTech Conference next week. Watch for coverage from the meeting and the broader medtech policy landscape at MyStrategist.com/market-pathways.
US Picks
Government shutdown realities, device import scrutiny:
As shutdown hits, FDA submissions must pause. A US federal government shutdown took hold October 1, adding more volatility to the federal workforce and gaps in some services. FDA will be in a relatively stable position compared to other agencies because so many of its staffers are funded by industry user fees rather than appropriations and many others who are necessary to conduct public safety efforts like high-risk recalls. But the shutdown legally blocks the agency from accepting any new premarket submissions that would require collection of new user fees. The impact of such a submission pause will depend on how long the shutdown lasts. As of Wednesday, the White House and congressional Democrats appear far from reaching an agreement to fund the government. Here are key points for medtech companies as the shutdown sets in:
- FDA Commissioner Marty Makary, MD, according to news reports, has told staff that the agency is exempt from potential efforts by the administration to fire federal employees not linked to mandatory program
- HHS says FDA will retain 86% of its staff who are either funded by user fees or who are designated as critical. The remaining 14% are furloughed during the impasse, according to FDA contingency plans posted last week.
- Reviewers can continue to work on device application reviews that were already in progress before October 1 for as long as device user fee reserve money lasts (a period that could range from several weeks to several months).
- The shutdown bars FDA from accepting any new submissions requiring user fees, including PMAs, 510(k)s, and De Novos.
- CMS will furlough 47% of its staff and HHS overall will temporarily lay off 41% of its workforce during the shutdown, according to the most recent contingency plans.
