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

There's one decision that comes up again and again in US market entry projects: treating the choice of US Agent like a quote comparison. "It's just an address on a form — might as well go with whoever's cheapest." From a working-level perspective, that's a perfectly reasonable call. The problem is the assumption behind it. If a US Agent's job really were nothing more than renting out an address, that would be the right choice. But look at the actual responsibilities FDA regul

November 25, 2024 The FDA’s recently issued guidance on orthopedic non-spinal bone plates, screws, and washers outlines crucial updates...