510k Modernization in progress
In our live webinar of January 2019 “Making American Guidance Understandable Again”, we highlighted a range of FDA initiatives towards a modernization of the US Medical Device Regulations. During that...
All Together Now – FDA Builds Devices Super Office
The biggest difference between the FDA way and the rest of the world is the separation of activities into device assessment, which comes first and involves FDA reviewers from the...
FDA raises fees 4%
The new US financial year as always heralds increases in regulatory fees. FDA published its 2019 fees at end of July. Fees are up around 4% across the board. The...
