FDA to Hold Public Meeting on Proposed Medical Device Review Recommendations
Key Takeaway: The FDA announced a public meeting and request for comments on proposed Medical Device User Fee Amendments (MDUFA )recommendations for fiscal years 2028-2032, which would govern medical device...
FDA to Drop 510(k) Requirements for Certain Low-Risk Devices, Lowering Barriers to Entry
On June 5, 2026, the U.S. Food and Drug Administration (FDA) issued updated guidance stating its intent to exempt certain unclassified medical devices from premarket 510(k) requirements, and that the FDA believes the identified device...
Eyeing the Prize of the U.S. Patent System, the Trump Administration Proposes Patent Maintenance Fee Overhaul
The Trump administration is considering changing the U.S. patent maintenance fee structure from the existing three fixed flat fees to an annual, value‑based “tax” model where patent holders would pay...
Subscribe for News and Updates
