Market Pathways covers the people, challenges, and opportunities impacting the global medtech regulatory, reimbursement, and policy communities. We invite you to explore our coverage. Think Strategically.
Subscribe Today
Each month in Global Spotlight we provide market access facts from the country highlighted on the cover of Market Pathways' print issue. The August 2025 cover features Parliament House in downtown Singapore.
The US agency published its annual notice announcing fees it will charge device companies next fiscal year. Included in the report, an extra rise in facility registration fees stemming from performance gains FDA made prior to recent staffing cuts at the device center. FDA also issued an updated guide on small business discount and waiver requests.
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Predetermined Change Control Plans in August 2025. Updated August 7.