Companies preparing to enter the US medical device market should take note of a recent FDA announcement. FDA has finalized the FY2027 medical device user fees in the Federal Register. The new rates run from October 1, 2026 through September 30, 2027. On the surface, this looks like a routine annual notice. It isn't quite that simple. The current fee framework, MDUFA V (2023-2027), closes out with this fiscal year. FDA user fees don't stay fixed indefinitely — Congress renegot

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,...