There's a quiet hope that keeps circulating among medical device companies eyeing the US market. "Maybe the next round of reforms will finally speed things up." Application volume keeps climbing while the reviewer headcount stays flat, so the thinking goes that the next policy overhaul has to bring some relief. The signal FDA just sent points the other way. Not faster. Tighter. MDUFA Isn't Just a Fee Schedule — It's a Five-Year Deal Between FDA and Industry Getting a device o

On July 30, 2025, the U.S. FDA announced the Medical Device User Fees applicable for Fiscal Year 2026 (October 1, 2025 – September 30,...

November 26, 2024 For medical device manufacturers, navigating the FDA's regulatory requirements is a critical step in bringing products...